Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
Purpose
This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Conditions
- Anal Basaloid Carcinoma
- Anal Canal Cloacogenic Carcinoma
- Anal Margin Squamous Cell Carcinoma
- Stage IIB Anal Cancer AJCC v8
- Stage IIIA Anal Cancer AJCC v8
- Stage IIIB Anal Cancer AJCC v8
- Stage IIIC Anal Cancer AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- REGISTRATION TO STEP 1 ELIGIBILITY CRITERIA
- Patients must have histologically proven stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB
(T4N0M0), or IIIC (T3N1M0, T4N1M0) invasive squamous cell carcinoma of the anus or
anorectum, according to the American Joint Committee on Cancer (AJCC) 8th edition;
this may include tumors of non-keratinizing histology such as basaloid, transitional
cell, or cloacogenic histology; individuals with squamous cell carcinoma of the anal
margin are eligible if there is evidence of extension of the primary tumor into the
anal canal
- For patients registering to Arm T, patients must not have received prior
chemoradiotherapy for anal cancer
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Patients must have hemoglobin levels of > 9 g/dL (within 2 weeks prior to
registration)
- Patient must have a platelet count of > 100,000/mm^3 (within 2 weeks prior to
registration)
- Patient's absolute neutrophil count (ANC) level must be > 1500/mm^3 (within 2 weeks
prior to registration)
- Serum creatinine must be =< 1.5 X upper limit of normal (ULN) (within 2 weeks prior to
registration)
- Total bilirubin must be < 2 X ULN (within 2 weeks prior to registration)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =<
2.5 X institutional upper limit of normal (within 2 weeks prior to registration)
- Albumin >= 3.0 g/dL (within 2 weeks prior to registration)
- Patients known to be human immunodeficiency virus (HIV)+ are permitted; patients with
CD4 > 200 and serum HIV viral load of < 200 copies/mm^3 are eligible, and in addition:
- Participants must be purified protein derivative (PPD) negative; alternatively,
the QuantiFERON-tuberculosis (TB) Gold In-Tube (QFT-GIT) assay (Cellestis
Limited, Carnegie, Australia) can be used; an individual is considered positive
for M. tuberculosis infection if the IFN-gamma response to TB antigens is above
the test cut-off (after subtracting the background IFN-gamma response in the
negative control); the result must be obtained within 20 weeks prior to
enrollment; PPD positive (or Quantiferon assay positive) participants are
permitted if prophylaxis has been completed prior to enrollment
- No history of acquired immune deficiency syndrome (AIDS)-related complications
within past year other than a history of low CD4+ T-cell count > 200/mm^3 prior
to initiation of combination antiretroviral therapy; on study CD4+ T-cell count
may not be informative due to chemoradiotherapy and should not be used as an
exclusion criterion if low
- Patient must be healthy on the basis of HIV disease with high likelihood of near
normal life span were it not for the anal cancer
- Participants MUST receive appropriate care and treatment for HIV infection,
including antiretroviral medications when clinically indicated, and should be
under the care of a physician experienced in HIV management; participants will be
eligible regardless of antiretroviral medication (including no antiretroviral
medication) provided there is no intention to initiate therapy or the regimen has
been stable for at least 4 weeks with no intention to change the regimen within
12 weeks following enrollment
- Patient must have =< grade 2 diarrhea (participants with grade 1 diarrhea are
eligible provided stool for ova/parasites and stool cryptosporidium studies are
negative;
- NOTE: HIV testing is not required for eligibility
- For patients registering prior to start of chemoradiotherapy, baseline scans must have
been completed within 4 weeks prior to registration
- Patients with an allogenic bone marrow/stem, cell or solid organ transplant are
excluded
- Women of child-bearing potential must use an accepted and effective method of
contraception and/or abstain from sexual intercourse while on protocol treatment and
for at least 5 months after the last dose of nivolumab; sexually active males must use
an accepted and effective method of contraception and/or abstain from sexual
intercourse while on protocol treatment and for at least 7 months after the last dose
of nivolumab
- Women MUST NOT be pregnant or breast-feeding due to the potential teratogenic harm or
abortifacient effects to an unborn fetus and possible risk for adverse events in
nursing infants with the treatment regimens being used; all patients must also not
expect to conceive or father children from study registration and throughout their
time on study treatment; for female patients this must continue until at least 5
months after the last dose of nivolumab and for male patients until at least 7 months
after the last dose of nivolumab; all females of child bearing potential must have a
serum or urine pregnancy test to rule out pregnancy within 2 weeks prior to
registration; a female of childbearing potential is any woman, regardless of sexual
orientation or whether they have undergone tubal ligation, who meets the following
criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy
or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea
following cancer therapy does not rule out childbearing potential) for at least 24
consecutive months (i.e., has had menses at any time in the preceding 24 consecutive
months)
- Patients will be excluded if they have a T1 or M1, and T2N0 cancer
- Patients must not have had prior potentially curative surgery (abdominal, peritoneal
resection) for carcinoma of the anus
- Participants may not be receiving any other standard anti-cancer therapy or
experimental agent concurrently with the study drugs
- Any surgery must have been completed >= 4 weeks prior to starting study treatment
- No uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements
- Individuals with a history of a different malignancy are ineligible except if they
have been disease-free for at least 2 years and are deemed by the investigator to be
at low risk for recurrence; individuals with the following cancers are eligible if
diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell
or squamous cell carcinoma of the skin
- Patient must not have active autoimmune disease in the past 2 years
- NOTE: This does not include patients with autoimmune disease controlled by
medication, such as hypothyroidism
- No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1,
anti-PD-L2, anti-CTLA4 monoclonal antibody)
- No patients with immunodeficiency or receiving nivolumab equivalent to > 10 mg
prednisone per day or any other form of immunosuppressive therapy within 7 days prior
to the first dose of study medication; topical corticosteroid or occasional inhaled
corticosteroids are allowed
- No live vaccines within 30 days prior to registration; examples of live vaccines
include, but are not limited to, the following: measles, mumps, rubella, chicken pox,
yellow fever, rabies, BCG, and typhoid (oral) vaccine; seasonal influenza vaccines for
injection are generally killed virus vaccines and are allowed; however, intranasal
influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines and are not allowed;
NOTE: no live vaccines may be administered while participating in the trial
- Patients must not have known interstitial lung disease that is symptomatic or may
interfere with the detection or management of suspected drug-related pulmonary
toxicity
- Previously irradiated patients (Arm S) must have received radiation per National
Comprehensive Cancer Network guidelines; radiation therapy delivered on protocol (Arm
T) will be reviewed
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients will be registered within 63
days following completion of standard chemoradiation for anal cancer; standard
chemoradiation therapy is as defined
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must have histologically proven
stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0)
invasive squamous cell carcinoma of the anus or anorectum, according to the AJCC 8th
edition; this may include tumors of non-keratinizing histology such as basaloid,
transitional cell, or cloacogenic histology; individuals with squamous cell carcinoma
of the anal margin are eligible if there is evidence of extension of the primary tumor
into the anal canal
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must have received at least 54
gray (Gy) of radiation to the PTVp (primary) and 45 Gy to PTVn (elective nodal region)
for the treatment of the anal cancer
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must have ECOG performance
status of 0-2
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must have hemoglobin levels of >
10 g/dL (within 2 weeks prior to registration)
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patient must have a platelet count of >
100,000/mm^3 (within 2 weeks prior to registration)
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patient's ANC level must be > 1500/mm^3
(within 2 weeks prior to registration)
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Serum creatinine must be =< 1.5 X ULN
(within 2 weeks prior to registration)
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Total bilirubin must be < 2 X ULN (within
2 weeks prior to registration)
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: AST (SGOT)/ALT (SGPT) =< 2.5 X
institutional upper limit of normal (within 2 weeks prior to registration)
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Albumin >= 3.0 g/dL (within 2 weeks prior
to registration)
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients known to be human
immunodeficiency virus (HIV)+ patients with CD4 > 200 and serum HIV viral load of <
200 copies/mm^3 are eligible; in addition:
- Participants must be PPD negative; alternatively, the QuantiFERON-TB Gold In-Tube
(QFT-GIT) assay (Cellestis Limited, Carnegie, Australia) can be used; an
individual is considered positive for M. tuberculosis infection if the IFN-gamma
response to TB antigens is above the test cut-off (after subtracting the
background IFN-gamma response in the negative control); the result must be
obtained within 20 weeks prior to enrollment; PPD positive (or Quantiferon assay
positive) participants are permitted if prophylaxis has been completed prior to
enrollment; NOTE: If patient completed chemoradiation on Step 1, PPD testing does
not need to be performed again
- No history of AIDS-related complications within past year other than a history of
low CD4+ T-cell count > 200/mm^3 prior to initiation of combination
antiretroviral therapy; on study CD4+ T-cell count may not be informative due to
chemoradiotherapy should not be used as an exclusion criterion if low
- Patient must be healthy on the basis of HIV disease with high likelihood of near
normal life span were it not for the anal cancer
- Participants MUST receive appropriate care and treatment for HIV infection,
including antiretroviral medications when clinically indicated, and should be
under the care of a physician experienced in HIV management; participants will be
eligible regardless of antiretroviral medication (including no antiretroviral
medication) provided there is no intention to initiate therapy or the regimen has
been stable for at least 4 weeks with no intention to change the regimen within
12 weeks following enrollment
- Patient must have =< grade 2 diarrhea (participants with grade 1 diarrhea are
eligible provided stool for ova/parasites and stool cryptosporidium studies are
negative)
- NOTE: HIV testing is not required for eligibility
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Scans done within 4 weeks of
randomization to Step 2
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patient must have recovered from all
toxicities associated with chemoradiotherapy for anal cancer, to grade =< 1 with the
exception of alopecia
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients with an allogenic bone
marrow/stem, cell or solid organ transplant are excluded
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Women of child-bearing potential must use
an accepted and effective method of contraception and/or abstain from sexual
intercourse while on protocol treatment and for at least 5 months after the last dose
of nivolumab; sexually active males must use an accepted and effective method of
contraception and/or abstain from sexual intercourse while on protocol treatment and
for at least 7 months after the last dose of nivolumab
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Women MUST NOT be pregnant or
breast-feeding due to the potential teratogenic harm or abortifacient effects to an
unborn fetus and possible risk for adverse events in nursing infants with the
treatment regimens being used; all patients must also not expect to conceive or father
children from study registration and throughout their time on study treatment; for
female patients this must continue until at least 5 months after the last dose of
nivolumab and for male patients until at least 7 months after the last dose of
nivolumab; all females of child bearing potential must have a serum or urine pregnancy
test to rule out pregnancy within 2 weeks prior to registration; a female of
childbearing potential is any woman, regardless of sexual orientation or whether they
have undergone tubal ligation, who meets the following criteria: 1) has achieved
menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy,
or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does
not rule out childbearing potential) for at least 24 consecutive months (i.e., has had
menses at any time in the preceding 24 consecutive months)
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Patients must not have had prior
potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the
anus
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Participants may not be receiving any
other standard anti-cancer therapy or experimental agent concurrently with the study
drugs
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: No uncontrolled intercurrent illness
including, but not limited to ongoing or active infection, symptomatic congestive
heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements
- REGISTRATION TO STEP 2 ELIGIBILITY CRITERIA: Individuals with a history of a different
malignancy are ineligible except if they have been disease-free for at least 2 years
and are deemed by the investigator to be at l
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A (nivolumab) |
Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
|
|
Other Arm B (clinical observation) |
Patients undergo observation for up to 6 months. |
|
Recruiting Locations
Birmingham, Alabama 35233
Anchorage, Alaska 98508
Anchorage, Alaska 99504
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Fairbanks, Alaska 99701
Kingman, Arizona 86401
Phoenix, Arizona 85054
Site Public Contact
855-776-0015
Scottsdale, Arizona 85259
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855-776-0015
Fort Smith, Arkansas 72903
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800-378-9373
Hot Springs, Arkansas 71913
Jonesboro, Arkansas 72401
Little Rock, Arkansas 72205
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501-686-8274
Anaheim, California 92806
Antioch, California 94531
Arroyo Grande, California 93420
Auburn, California 95602
Auburn, California 95603
Baldwin Park, California 91706
Bellflower, California 90706
Berkeley, California 94704
Burbank, California 91505
Burlingame, California 94010
Cameron Park, California 95682
Castro Valley, California 94546
Chico, California 95926
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530-332-3808
Clovis, California 93611
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559-387-1827
Clovis, California 93611
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Davis, California 95616
Dublin, California 94568
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Fontana, California 92335
Fremont, California 94538
Fremont, California 94538
Fresno, California 93720
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Harbor City, California 90710
Irvine, California 92618
La Jolla, California 92093
Los Angeles, California 90027
Los Angeles, California 90033
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323-865-0451
Los Angeles, California 90033
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323-865-0451
Los Angeles, California 90034
Marysville, California 95901
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Modesto, California 95355
Modesto, California 95356
Mountain View, California 94040
Mountain View, California 94040
Newport Beach, California 92663
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323-865-0451
Oakland, California 94611
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Meridian, Idaho 83642
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Twin Falls, Idaho 83301
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312-355-3046
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Effingham, Illinois 62401
Eureka, Illinois 61530
Evanston, Illinois 60201
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847-570-2109
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Galesburg, Illinois 61401
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309-344-2831
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847-570-2109
Kewanee, Illinois 61443
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317-528-7060
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Bettendorf, Iowa 52722
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Des Moines, Iowa 50309
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515-241-6727
Des Moines, Iowa 50309
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Des Moines, Iowa 50316
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515-241-8704
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Iowa City, Iowa 52242
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Olathe, Kansas 66061
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Louisville, Kentucky 40202
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502-562-3429
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Louisville, Kentucky 40215
Louisville, Kentucky 40245
Madisonville, Kentucky 42431
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270-575-2928
Shepherdsville, Kentucky 40165
Metairie, Louisiana 70006
New Orleans, Louisiana 70112
Baltimore, Maryland 21204
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443-849-3706
Boston, Massachusetts 02118
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617-638-8265
Fitchburg, Massachusetts 01420
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Springfield, Massachusetts 01104
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413-748-9234
Worcester, Massachusetts 01655
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48109
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800-865-1125
Battle Creek, Michigan 49017
Bay City, Michigan 48706
Bloomfield, Michigan 48302
Brighton, Michigan 48114
Brighton, Michigan 48114
Brighton, Michigan 48116
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800-865-1125
Brownstown, Michigan 48183
Canton, Michigan 48188
Canton, Michigan 48188
Caro, Michigan 48723
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Clinton Township, Michigan 48038
Dearborn, Michigan 48124
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248-551-7695
Dearborn, Michigan 48126
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Detroit, Michigan 48202
Detroit, Michigan 48236
East China Township, Michigan 48054
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Farmington Hills, Michigan 48336
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248-551-7695
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48532
Flint, Michigan 48532
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Jackson, Michigan 49201
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49048
Lansing, Michigan 48910
Lansing, Michigan 48912
Lansing, Michigan 48912
Lapeer, Michigan 48446
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Livonia, Michigan 48154
Macomb, Michigan 48044
Macomb, Michigan 48044
Marlette, Michigan 48453
Mount Clemens, Michigan 48043
Mount Pleasant, Michigan 48858
Muskegon, Michigan 49444
Niles, Michigan 49120
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616-391-1230
Norton Shores, Michigan 49444
Novi, Michigan 48374
Novi, Michigan 48377
Petoskey, Michigan 49770
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Port Huron, Michigan 48060
Reed City, Michigan 49677
Rochester Hills, Michigan 48309
Royal Oak, Michigan 48067
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Royal Oak, Michigan 48073
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Royal Oak, Michigan 48073
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Royal Oak, Michigan 48073
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Royal Oak, Michigan 48073
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Royal Oak, Michigan 48073
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Saginaw, Michigan 48601
Saginaw, Michigan 48604
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Shelby, Michigan 48315
Southfield, Michigan 48075
Sterling Heights, Michigan 48312
Sterling Heights, Michigan 48312
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Tawas City, Michigan 48764
Traverse City, Michigan 49684
Troy, Michigan 48084
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Troy, Michigan 48085
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Troy, Michigan 48098
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Warren, Michigan 48088
Warren, Michigan 48093
Warren, Michigan 48093
Warren, Michigan 48093
Warren, Michigan 48093
West Bloomfield, Michigan 48322
West Branch, Michigan 48661
Wyoming, Michigan 49519
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48197
Aitkin, Minnesota 56431
Bemidji, Minnesota 56601
Brainerd, Minnesota 56401
Burnsville, Minnesota 55337
Cambridge, Minnesota 55008
Coon Rapids, Minnesota 55433
Deer River, Minnesota 56636
Detroit Lakes, Minnesota 56501
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Edina, Minnesota 55435
Fergus Falls, Minnesota 56537
Fosston, Minnesota 56542
Fridley, Minnesota 55432
Hibbing, Minnesota 55746
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Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55454
Monticello, Minnesota 55362
New Ulm, Minnesota 56073
Park Rapids, Minnesota 56470
Princeton, Minnesota 55371
Robbinsdale, Minnesota 55422
Rochester, Minnesota 55905
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Saint Louis Park, Minnesota 55416
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55102
Sandstone, Minnesota 55072
Shakopee, Minnesota 55379
Stillwater, Minnesota 55082
Thief River Falls, Minnesota 56701
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Virginia, Minnesota 55792
Waconia, Minnesota 55387
Willmar, Minnesota 56201
Woodbury, Minnesota 55125
Worthington, Minnesota 56187
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Wyoming, Minnesota 55092
Grenada, Mississippi 38901
New Albany, Mississippi 38652
Oxford, Mississippi 38655
Southhaven, Mississippi 38671
Ballwin, Missouri 63011
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Branson, Missouri 65616
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Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
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Creve Coeur, Missouri 63141
Farmington, Missouri 63640
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Jefferson City, Missouri 65109
Joplin, Missouri 64804
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Rolla, Missouri 65401
Rolla, Missouri 65401
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Saint Joseph, Missouri 64506
Saint Louis, Missouri 63109
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Saint Louis, Missouri 63110
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Saint Louis, Missouri 63141
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Saint Peters, Missouri 63376
Sainte Genevieve, Missouri 63670
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Springfield, Missouri 65804
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Springfield, Missouri 65807
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Sullivan, Missouri 63080
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Sunset Hills, Missouri 63127
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Washington, Missouri 63090
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636-390-1600
Anaconda, Montana 59711
Billings, Montana 59101
Billings, Montana 59101
Billings, Montana 59102
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800-648-6274
Bozeman, Montana 59715
Butte, Montana 59701
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406-723-2621
Great Falls, Montana 59405
Great Falls, Montana 59405
Kalispell, Montana 59901
Missoula, Montana 59802
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Grand Island, Nebraska 68803
Kearney, Nebraska 68847
Lincoln, Nebraska 68510
Omaha, Nebraska 68114
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Omaha, Nebraska 68122
Omaha, Nebraska 68124
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Papillion, Nebraska 68046
Carson City, Nevada 89703
Henderson, Nevada 89052
Henderson, Nevada 89052
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Las Vegas, Nevada 89148-2405
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Pahrump, Nevada 89048
Reno, Nevada 89502
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Reno, Nevada 89509
Lebanon, New Hampshire 03756
Basking Ridge, New Jersey 07920
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Middletown, New Jersey 07748
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Montvale, New Jersey 07645
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Moorestown, New Jersey 08057
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Morristown, New Jersey 07960
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Mount Holly, New Jersey 08060
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New Brunswick, New Jersey 08903
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Summit, New Jersey 07902
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Voorhees, New Jersey 08043
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Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87109
Bronx, New York 10461
Bronx, New York 10461
Bronx, New York 10467
Buffalo, New York 14263
Commack, New York 11725
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Glens Falls, New York 12801
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Harrison, New York 10604
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New York, New York 10029
New York, New York 10065
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Uniondale, New York 11553
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Chapel Hill, North Carolina 27599
Clinton, North Carolina 28328
Goldsboro, North Carolina 27534
Hendersonville, North Carolina 28791
Jacksonville, North Carolina 28546
Kenansville, North Carolina 28349
Kinston, North Carolina 28501
Raleigh, North Carolina 27607
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Richlands, North Carolina 28574
Winston-Salem, North Carolina 27157
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336-713-6771
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
Fargo, North Dakota 58103
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701-234-6161
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Jamestown, North Dakota 58401
Minot, North Dakota 58701
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Beachwood, Ohio 44122
Belpre, Ohio 45714
Chardon, Ohio 44024
Chillicothe, Ohio 45601
Cincinnati, Ohio 45219
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Cincinnati, Ohio 45242
Cincinnati, Ohio 45247
Cincinnati, Ohio 45255
Cleveland, Ohio 44106
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Columbus, Ohio 43210
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Delaware, Ohio 43015
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Dublin, Ohio 43016
Elyria, Ohio 44035
Grove City, Ohio 43123
Lancaster, Ohio 43130
Mansfield, Ohio 44903
Marietta, Ohio 45750
Marion, Ohio 43302
Mayfield Heights, Ohio 44124
Mentor, Ohio 44060
Middleburg Heights, Ohio 44130
Mount Vernon, Ohio 43050
Newark, Ohio 43055
Newark, Ohio 43055
Parma, Ohio 44129
Portsmouth, Ohio 45662
Ravenna, Ohio 44266
Sandusky, Ohio 44870
Wadsworth, Ohio 44281
West Chester, Ohio 45069
Westerville, Ohio 43081
Westlake, Ohio 44145
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Zanesville, Ohio 43701
Lawton, Oklahoma 73505
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Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73120
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Tulsa, Oklahoma 74146
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Baker City, Oregon 97814
Bend, Oregon 97701
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Newberg, Oregon 97132
Ontario, Oregon 97914
Portland, Oregon 97213
Portland, Oregon 97225
Portland, Oregon 97227
Portland, Oregon 97239
Redmond, Oregon 97756
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Allentown, Pennsylvania 18103
Bethlehem, Pennsylvania 18015
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Bethlehem, Pennsylvania 18017
Bryn Mawr, Pennsylvania 19010
Chadds Ford, Pennsylvania 19317
Collegeville, Pennsylvania 19426
Danville, Pennsylvania 17822
East Stroudsburg, Pennsylvania 18301
Exton, Pennsylvania 19341
Harrisburg, Pennsylvania 17101
Harrisburg, Pennsylvania 17109
Hazleton, Pennsylvania 18201
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Lewisburg, Pennsylvania 17837
Lewistown, Pennsylvania 17044
Media, Pennsylvania 19063
Paoli, Pennsylvania 19301
Philadelphia, Pennsylvania 19104
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Philadelphia, Pennsylvania 19107
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Philadelphia, Pennsylvania 19107
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Philadelphia, Pennsylvania 19111
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Philadelphia, Pennsylvania 19114
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Philadelphia, Pennsylvania 19140
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Pittsburgh, Pennsylvania 15232
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Pottsville, Pennsylvania 17901
State College, Pennsylvania 16801
West Reading, Pennsylvania 19611
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Wilkes-Barre, Pennsylvania 18711
Willow Grove, Pennsylvania 19090
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Wynnewood, Pennsylvania 19096
Clinton, South Carolina 29325
Easley, South Carolina 29640
Gaffney, South Carolina 29341
Greenville, South Carolina 29605
Greenville, South Carolina 29605
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Greenville, South Carolina 29615
Greer, South Carolina 29650
Greer, South Carolina 29651
Seneca, South Carolina 29672
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29307
Union, South Carolina 29379
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57117-5134
Collierville, Tennessee 38017
Franklin, Tennessee 37067
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Memphis, Tennessee 38120
Nashville, Tennessee 37204
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Nashville, Tennessee 37232
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Bryan, Texas 77802
Dallas, Texas 75235
Dallas, Texas 75390
Fort Worth, Texas 76104
Houston, Texas 77030
Richardson, Texas 75080
Farmington, Utah 84025
Salt Lake City, Utah 84106
Salt Lake City, Utah 84112
Berlin, Vermont 05602
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Burlington, Vermont 05401
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South Hill, Virginia 23970
Aberdeen, Washington 98520
Bellevue, Washington 98004
Bellingham, Washington 98225
Bremerton, Washington 98310
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Burien, Washington 98166
Centralia, Washington 98531
Edmonds, Washington 98026
Enumclaw, Washington 98022
Everett, Washington 98201
Federal Way, Washington 98003
Issaquah, Washington 98029
Kennewick, Washington 99336
Lacey, Washington 98503
Lakewood, Washington 98499
Longview, Washington 98632
Port Townsend, Washington 98368
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Poulsbo, Washington 98370
Renton, Washington 98055
Seattle, Washington 98104
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Seattle, Washington 98109
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Seattle, Washington 98109
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Seattle, Washington 98195
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Sedro-Woolley, Washington 98284
Shelton, Washington 98584
Tacoma, Washington 98405
Vancouver, Washington 98664
Walla Walla, Washington 99362
Yelm, Washington 98597
Bridgeport, West Virginia 26330
Martinsburg, West Virginia 25401
Morgantown, West Virginia 26506
Parkersburg, West Virginia 26101
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Burlington, Wisconsin 53105
Eau Claire, Wisconsin 54701
Fond Du Lac, Wisconsin 54937
Germantown, Wisconsin 53022
Grafton, Wisconsin 53024
Green Bay, Wisconsin 54311
Johnson Creek, Wisconsin 53038
Kenosha, Wisconsin 53142
La Crosse, Wisconsin 54601
Madison, Wisconsin 53792
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Marinette, Wisconsin 54143
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Milwaukee, Wisconsin 53209
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Minocqua, Wisconsin 54548
Mukwonago, Wisconsin 53149
New Richmond, Wisconsin 54017
Oconomowoc, Wisconsin 53066
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Oshkosh, Wisconsin 54904
Racine, Wisconsin 53406
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Sheboygan, Wisconsin 53081
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Two Rivers, Wisconsin 54241
Waukesha, Wisconsin 53188
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Waukesha, Wisconsin 53188
Wausau, Wisconsin 54401
Wauwatosa, Wisconsin 53226
West Allis, Wisconsin 53227
Weston, Wisconsin 54476
Cheyenne, Wyoming 82001
Cody, Wyoming 82414
Sheridan, Wyoming 82801
More Details
- NCT ID
- NCT03233711
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves disease-free survival (DFS) compared with observation in patients with high risk anal carcinoma.
SECONDARY OBJECTIVES:
I. To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with regard to:
Ia. Objective response rate (complete [CR] and partial [PR]), stable disease and progression.
Ib. Severe toxicity interval. Ic. Colostomy-free survival. Id. Overall survival. Ie. Toxicity.
OUTLINE: Patients who received standard CMT are randomized to 1 of 2 arms.
ARM A: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
ARM B: Patients undergo observation for up to 6 months.
After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.