Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Purpose
This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. This trial enrolls participants for the following cohorts based on condition: 1. Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx. 2. Epithelial tumors of major salivary glands 3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location 4. Undifferentiated carcinoma of gastrointestinal (GI) tract 5. Adenocarcinoma with variants of small intestine 6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) 7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary 8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma 9. Intrahepatic Cholangiocarcinoma 10. Extrahepatic cholangiocarcinoma and bile duct tumors 11. Sarcomatoid carcinoma of lung 12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma. 13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma 14. Trophoblastic tumor: A) Choriocarcinoma 15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder 16. Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex cord cancer B) Non seminomatous tumor C) Teratoma with malignant transformation 17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis 18. Squamous cell carcinoma variants of the genitourinary (GU) system 19. Spindle cell carcinoma of kidney, pelvis, ureter 20. Adenocarcinoma with variants of GU system (excluding prostate cancer) 21. Odontogenic malignant tumors 22. Endocrine carcinoma of pancreas and digestive tract 23. Neuroendocrine carcinoma including carcinoid of the lung 24. Pheochromocytoma, malignant 25. Paraganglioma 26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex 27. Desmoid tumors 28. Peripheral nerve sheath tumors and NF1-related tumors 29. Malignant giant cell tumors 30. Chordoma 31. Adrenal cortical tumors 32. Tumor of unknown primary (Cancer of Unknown Primary; CuP) 33. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org] 34. Adenoid cystic carcinoma 35. Vulvar cancer 36. MetaPLASTIC carcinoma (of the breast) 37. Gastrointestinal stromal tumor (GIST)
Conditions
- Acinar Cell Carcinoma
- Adenoid Cystic Carcinoma
- Adrenal Cortex Carcinoma
- Adrenal Gland Pheochromocytoma
- Anal Canal Neuroendocrine Carcinoma
- Anal Canal Undifferentiated Carcinoma
- Appendix Mucinous Adenocarcinoma
- Bartholin Gland Transitional Cell Carcinoma
- Bladder Adenocarcinoma
- Cervical Adenocarcinoma
- Cholangiocarcinoma
- Chordoma
- Colorectal Squamous Cell Carcinoma
- Desmoid-Type Fibromatosis
- Endometrial Transitional Cell Carcinoma
- Endometrioid Adenocarcinoma
- Esophageal Neuroendocrine Carcinoma
- Esophageal Undifferentiated Carcinoma
- Extrahepatic Bile Duct Carcinoma
- Fallopian Tube Adenocarcinoma
- Fallopian Tube Transitional Cell Carcinoma
- Fibromyxoid Tumor
- Gastric Neuroendocrine Carcinoma
- Gastric Squamous Cell Carcinoma
- Gastric Undifferentiated Carcinoma
- Gastrointestinal Stromal Tumor
- Giant Cell Carcinoma
- Intestinal Neuroendocrine Carcinoma
- Intrahepatic Cholangiocarcinoma
- Lung Carcinoid Tumor
- Lung Sarcomatoid Carcinoma
- Major Salivary Gland Carcinoma
- Malignant Odontogenic Neoplasm
- Malignant Peripheral Nerve Sheath Tumor
- Malignant Testicular Sex Cord-Stromal Tumor
- Metaplastic Breast Carcinoma
- Metastatic Malignant Neoplasm of Unknown Primary Origin
- Minimally Invasive Lung Adenocarcinoma
- Mixed Mesodermal (Mullerian) Tumor
- Mucinous Adenocarcinoma
- Mucinous Cystadenocarcinoma
- Nasal Cavity Adenocarcinoma
- Nasal Cavity Carcinoma
- Nasopharyngeal Carcinoma
- Nasopharyngeal Papillary Adenocarcinoma
- Nasopharyngeal Undifferentiated Carcinoma
- Oral Cavity Carcinoma
- Oropharyngeal Undifferentiated Carcinoma
- Ovarian Adenocarcinoma
- Ovarian Germ Cell Tumor
- Ovarian Mucinous Adenocarcinoma
- Ovarian Squamous Cell Carcinoma
- Ovarian Transitional Cell Carcinoma
- Pancreatic Acinar Cell Carcinoma
- Pancreatic Neuroendocrine Carcinoma
- Paraganglioma
- Paranasal Sinus Adenocarcinoma
- Paranasal Sinus Carcinoma
- Parathyroid Gland Carcinoma
- Pituitary Gland Carcinoma
- Placental Choriocarcinoma
- Placental-Site Gestational Trophoblastic Tumor
- Primary Peritoneal High Grade Serous Adenocarcinoma
- Pseudomyxoma Peritonei
- Rare Disorder
- Scrotal Squamous Cell Carcinoma
- Seminal Vesicle Adenocarcinoma
- Seminoma
- Serous Cystadenocarcinoma
- Small Intestinal Adenocarcinoma
- Small Intestinal Squamous Cell Carcinoma
- Spindle Cell Neoplasm
- Squamous Cell Carcinoma of the Penis
- Teratoma With Malignant Transformation
- Testicular Non-Seminomatous Germ Cell Tumor
- Thyroid Gland Carcinoma
- Tracheal Carcinoma
- Transitional Cell Carcinoma
- Ureter Adenocarcinoma
- Ureter Squamous Cell Carcinoma
- Urethral Adenocarcinoma
- Urethral Squamous Cell Carcinoma
- Vaginal Adenocarcinoma
- Vaginal Squamous Cell Carcinoma, Not Otherwise Specified
- Vulvar Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- Patients are eligible under ONE of the following criteria:
- Patients must have histologically confirmed rare cancer and must be able to
submit specimens; NOTE: Subsequent to site's Institutional Review Board (IRB)
approval of revision 3, patients are NOT required to participate in EAY131
"National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)"
to register to this study
- FOR PATIENTS ENROLLED IN EAY131 "NCI-MATCH" PRIOR TO EAY131 ADDENDUM 10 ONLY:
Patients must have histologically confirmed rare cancer that did not have a match
to a molecularly-guided therapy on EAY131 "NCI-MATCH" protocol or who are off
protocol treatment on EAY131, "NCI-MATCH" and have no further molecularly-matched
treatment recommendations per EAY131, "NCI-MATCH" or who are otherwise unable to
receive EAY131, "NCI-MATCH" therapy
- Patients that do not qualify for one of the histologic cohorts may be considered for
registration in the "Not Otherwise Categorized" Rare Tumors cohort with confirmation
of at least one of the study chairs via email
- Patients that are determined to have a rare cancer with unknown primary site are
eligible under cohort #32 (tumor of unknown primary [cancer of unknown primary; CuP]),
provided that there is histologic documentation of metastatic malignancy with no
discernible primary site identified from histopathologic review, physical exam and
associated cross-sectional imaging of the chest, abdomen, and pelvis
- Patients must have progressed following at least one line of standard systemic therapy
and there must not be other approved/standard therapy available that has been shown to
prolong overall survival (i.e. in a randomized trial against another standard
treatment or by comparison to historical controls); patients who cannot receive other
standard therapy that has been shown to prolonged survival due to medical issues will
be eligible, if other eligibility criteria are met; OR
- Patients for whose disease no standard treatment exists that has been shown to
prolong overall survival
- Patients must have a diagnostic quality computed tomography (CT) scan or magnetic
resonance imaging (MRI), performed within 28 days prior to registration, which
demonstrates measurable disease, as defined in RECIST v. 1.1; all disease must be
assessed and documented on the S1609 Baseline Tumor Assessment Form
- No other prior malignancy is allowed except for the following:
- Adequately managed stage I or II cancer from which the patient is currently in
complete remission
- Any other cancer from which the patient has been disease free for one year
- Adequately managed stage I or II follicular thyroid or prostate cancer is also
eligible, wherein patient is not required to be in complete remission
- Patients may have received prior anti-CTLA4 or other anti-PD-1/anti-PD-L1 therapy, not
both, provided that it is completed >= 4 weeks prior to registration
- Patients who had prior grade 3 or higher immune-related adverse event (e.g.
pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer
vaccine, cytokine, etc.) are not eligible
- Patients with clinically controlled thyroiditis or pituitary disorders on stable
replacement therapy are eligible
- Patients are not eligible if they have had or are planned for solid organ transplant;
patients who have received allogeneic hematopoietic stem cell transplant are eligible
if:
- The transplant occurred at least 90 days prior to registration,
- Patient has no prior acute graft versus host disease (GVHD), and
- Within 48 hours of registration, patient demonstrates at least 90% engraftment,
defined as: absolute neutrophil count (ANC) >= 500 mcl, measured over 3
consecutive days or 1 day with an ANC >= 1,000 mcl, or platelets >= 50,000 mcl
measured, wherein the patient did not receive any platelet transfusions within 7
days prior to laboratory assessment
- Patients with autoimmune disease who are otherwise eligible must not have received
steroid and immunosuppressive therapy within 28 days prior to registration
- Patients with brain metastases or primary brain tumors must have completed treatment,
surgery or radiation therapy >= 28 days prior to registration and have stable disease
at time of registration; metastatic brain parenchymal disease must have been treated
and patient must be off steroids for 7 days prior to registration; patients must have
a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease
within 42 days prior to registration
- Patients must not currently be receiving any other investigational agents or any other
systemic anti-cancer therapy (including radiation, excluding RANKL inhibitors and
bisphosphonates); in event patient recently received any other systemic anti-cancer
therapy, patient must be off therapy at least 7 days prior to registration and any
therapy-induced toxicity must have recovered to =< grade 1, except alopecia and =<
grade 2 neuropathy which are allowed; any planned radiation therapy must be completed
before enrollment onto S1609
- Patients must not have prior history of allergy or known hypersensitivity to nivolumab
or ipilimumab
- Patients must have a Zubrod performance status of 0-2
- Within 28 days prior to registration: ANC >= 1,000/mcL
- Within 28 days prior to registration: Platelets >= 75,000/mcL
- Within 28 days prior to registration: Hemoglobin >= 8 g/dL
- Within 28 days prior to registration: Total bilirubin =< 2.0 x institutional upper
limit of normal (IULN) or for documented/suspected Gilbert's disease, total bilirubin
=< 3.0 x IULN
- Within 28 days prior to registration: Aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) both =< 3 x IULN
- Within 28 days prior to registration: Serum creatinine =< 2.0 x IULN
- Within 28 days prior to registration: Creatinine clearance (CrCl) >= 50 mL/min., as
estimated by the Cockcroft and Gault formula; estimated creatinine clearance is based
on actual body weight
- Patients must have adequate thyroid function, as evidenced by either
thyroid-stimulating hormone (TSH) or, free thyroxine (T4) serum tests demonstrating
values within the normal range, within 28 days prior to registration; Note: TSH, with
reflex T4 is allowable if per institutional standard; otherwise, both TSH and free-T4
must be obtained
- Patients must have adequate adrenal axis function, as evidenced by adrenocorticotropic
hormone (ACTH) values within the institutional normal ranges OR cortisol levels within
institutional normal ranges (ante meridiem [AM] cortisol preferred), within 28 days
prior to registration
- Females of childbearing potential must have negative serum or urine pregnancy test 7
days prior to registration and agree to use birth control throughout study and for 23
weeks after completion of protocol therapy; patients must not be pregnant or nursing;
women/men of reproductive potential must have agreed to use an effective contraceptive
method; a woman is considered to be of "reproductive potential" if she has had menses
at any time in the preceding 12 consecutive months; in addition to routine
contraceptive methods, "effective contraception" also includes heterosexual celibacy
and surgery intended to prevent pregnancy (or with a side-effect of pregnancy
prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal
ligation; however, if at any point a previously celibate patient chooses to become
heterosexually active during the time period for use of contraceptive measures
outlined in the protocol, he/she is responsible for beginning contraceptive measures
- Men of reproductive potential must have agreed to use birth control throughout the
study and for 31 weeks after completion of protocol therapy; in addition to routine
contraceptive methods, "effective contraception" also includes heterosexual celibacy
and surgery intended to prevent pregnancy (vasectomy); however, if at any point a
previously celibate patient chooses to become heterosexually active during the time
period for use of contraceptive measures outlined in the protocol, he is responsible
for beginning contraceptive measures
- Patients must not have known active hepatitis B virus (HBV) or hepatitis virus (HCV)
infection at time of registration; patients with HBV or HCV that have an undetectable
viral load, or in the opinion of the treating investigator is well-controlled, are
eligible
- Patients who are known to be human immunodeficiency virus (HIV)-positive at
registration are eligible at the time of registration:
1. Cluster of differentiation (CD)4+ cell count greater or equal to 250 cells/mm^3
2. If patient is on antiretroviral therapy, there must be minimal interactions or
overlapping toxicity of the antiretroviral therapy with the experimental cancer
treatment; once daily combinations that use pharmacologic boosters may not be
used
3. No history of non-malignancy acquired immunodeficiency syndrome (AIDS)-defining
conditions other than historical low CD4+ cell counts
- Patients must not have active autoimmune disease that has required systemic treatment
in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs,
or corticosteroids with doses higher than prednisone 10mg or equivalent); replacement
therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy
for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic
treatment; autoimmune diseases include but are not limited to autoimmune hepatitis,
inflammatory bowel disease (including ulcerative colitis and Chron's disease), as well
as symptomatic disease (e.g. rheumatoid arthritis, systemic progressive sclerosis
[scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's
Granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g.,
Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or
glomerulonephritis); vitiligo, alopecia, hypothyroidism on stable doses of thyroid
replacement therapy, psoriasis not requiring systemic therapy within the past 2 years
is permitted; short-term steroid premedication for contrast allergy is permitted
- Patients must not have any uncontrolled intercurrent illness including (not limited
to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA]
III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks
prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of
NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2),
known psychiatric illness that would limit study compliance, intra-cardiac
defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>=
grade 3)
- Note: Patients with history of CHF or patients who are deemed at risk because of
underlying cardiovascular disease or exposure to cardiotoxic drugs should have an
electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at
baseline and at the start of each cycle; patients who have evidence at baseline
(or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis
cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist,
including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram,
as clinically indicated
- Patients must have amylase or lipase within =< 1.5 x IULN without symptoms of
pancreatitis at registration, within 28 days prior to registration
- Patients must not have symptomatic interstitial lung disease or pneumonitis
- Patients must have fully recovered from any adverse effects of major surgery (to =<
grade 1) at least 14 days prior to registration
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment (nivolumab, ipilimumab) |
Patients receive nivolumab IV over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 60 minutes on day 1. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. |
|
Recruiting Locations
Birmingham, Alabama 35233
Mobile, Alabama 36688
Anchorage, Alaska 98508
Anchorage, Alaska 99504
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Fairbanks, Alaska 99701
Phoenix, Arizona 85004
Fort Smith, Arkansas 72903
Site Public Contact
800-378-9373
Hot Springs, Arkansas 71913
Jonesboro, Arkansas 72401
Little Rock, Arkansas 72205
Site Public Contact
501-686-8274
Anaheim, California 92806
Antioch, California 94531
Arroyo Grande, California 93420
Auburn, California 95602
Auburn, California 95603
Bakersfield, California 93301
Site Public Contact
661-323-4673
Baldwin Park, California 91706
Bellflower, California 90706
Berkeley, California 94704
Burbank, California 91505
Burlingame, California 94010
Cameron Park, California 95682
Castro Valley, California 94546
Costa Mesa, California 92627
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877-827-8839
Davis, California 95616
Duarte, California 91010
Dublin, California 94568
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925-875-1677
Emeryville, California 94608
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510-835-9900
Emeryville, California 94608
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510-629-6682
Fontana, California 92335
Fremont, California 94538
Fremont, California 94538
Fresno, California 93720
Harbor City, California 90710
Irvine, California 92618
La Jolla, California 92093
Loma Linda, California 92354
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909-558-3375
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
Los Angeles, California 90048
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310-423-8965
Martinez, California 94553-3156
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925-957-5400
Marysville, California 95901
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530-749-4400
Merced, California 95340
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Modesto, California 95355
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Novato, California 94945
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Rancho Mirage, California 92270
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Washington, District of Columbia 20007
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Boise, Idaho 83706
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Meridian, Idaho 83642
Nampa, Idaho 83686
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Post Falls, Idaho 83854
Sandpoint, Idaho 83864
Twin Falls, Idaho 83301
Aurora, Illinois 60504
Bloomington, Illinois 61704
Canton, Illinois 61520
Carbondale, Illinois 62902
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Carthage, Illinois 62321
Centralia, Illinois 62801
Chicago, Illinois 60608
Chicago, Illinois 60611
Chicago, Illinois 60612
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312-864-5204
Chicago, Illinois 60612
Chicago, Illinois 60637
Chicago, Illinois 60657
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773-296-5360
Danville, Illinois 61832
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Effingham, Illinois 62401
Effingham, Illinois 62401
Eureka, Illinois 61530
Galesburg, Illinois 61401
Galesburg, Illinois 61401
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309-344-2831
Geneva, Illinois 60134
Harvey, Illinois 60426
Kewanee, Illinois 61443
Lake Forest, Illinois 60045
Macomb, Illinois 61455
Mattoon, Illinois 61938
Maywood, Illinois 60153
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708-226-4357
Melrose Park, Illinois 60160
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708-450-4554
Mount Vernon, Illinois 62864
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618-242-4600
New Lenox, Illinois 60451
Orland Park, Illinois 60462
Ottawa, Illinois 61350
Pekin, Illinois 61554
Pekin, Illinois 61554
Peoria, Illinois 61615
Peoria, Illinois 61615
Peoria, Illinois 61636
Peoria, Illinois 61637
Peru, Illinois 61354
Peru, Illinois 61354
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815-664-4141
Princeton, Illinois 61356
Springfield, Illinois 62702
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217-545-7929
Springfield, Illinois 62702
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800-444-7541
Springfield, Illinois 62781
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217-788-3528
Swansea, Illinois 62226
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Urbana, Illinois 61801
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Warrenville, Illinois 60555
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Avon, Indiana 46123
Carmel, Indiana 46032
Evansville, Indiana 47713
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Indianapolis, Indiana 46290
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South Bend, Indiana 46601
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800-284-7370
Ames, Iowa 50010
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515-956-4132
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515-956-4132
Cedar Rapids, Iowa 52403
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319-365-4673
Cedar Rapids, Iowa 52403
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319-363-2690
Clive, Iowa 50325
Clive, Iowa 50325
Council Bluffs, Iowa 51503
Creston, Iowa 50801
Des Moines, Iowa 50309
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515-241-6727
Des Moines, Iowa 50309
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515-282-2921
Des Moines, Iowa 50314
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515-282-2200
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Des Moines, Iowa 50316
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515-241-8704
Fort Dodge, Iowa 50501
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515-956-4132
Fort Dodge, Iowa 50501
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515-574-8302
Jefferson, Iowa 50129
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515-956-4132
Marshalltown, Iowa 50158
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515-956-4132
West Des Moines, Iowa 50266-7700
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515-343-1000
West Des Moines, Iowa 50266
Chanute, Kansas 66720
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Wyoming, Minnesota 55092
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Grand Island, Nebraska 68803
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Lebanon, New Hampshire 03756
Manchester, New Hampshire 03102
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Albuquerque, New Mexico 87102
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Buffalo, New York 14263
Glens Falls, New York 12801
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Asheville, North Carolina 28803
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Goldsboro, North Carolina 27534
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Bismarck, North Dakota 58501
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Chattanooga, Tennessee 37404
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Franklin, Tennessee 37067
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Chippewa Falls, Wisconsin 54729
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Weston, Wisconsin 54476
Wisconsin Rapids, Wisconsin 54494
Cheyenne, Wyoming 82001
Cody, Wyoming 82414
Sheridan, Wyoming 82801
More Details
- NCT ID
- NCT02834013
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy.
SECONDARY OBJECTIVES:
I. To evaluate toxicities in each cohort. II. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria.
TERTIARY OBJECTIVES:
I. To evaluate the association of tumor mutational burden measured by tissue sequencing with durable response (complete response [CR] or partial response [PR] lasting 24 weeks or more).
II. To describe the mutational load and targeted sequencing of well-known oncogenes and changes in these markers of patients at up to three time points (baseline, cycle 2, and progression), and across strata to describe associations with survival outcomes.
III. To describe the presence of germline mutations, and across strata to evaluate association with outcome.
IV. Within strata, to describe patient risk category as defined by the biodesix protein signature and change over time at up to three time points (baseline, cycle 2, progression), and across strata to evaluate associations with outcomes.
V. Within strata, to evaluate the association of PD-L1 expression (positive versus negative) with response and survival outcomes, and within strata, to characterize baseline PD-L1 prevalence.
VI. To collect specimens for banking for use in future correlative biomarker research studies.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 60 minutes on day 1. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 10 years from registration.