Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Purpose
This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). 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. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.
Conditions
- Advanced Esophageal Adenocarcinoma
- Advanced Gastric Adenocarcinoma
- Advanced Gastroesophageal Junction Adenocarcinoma
- Clinical Stage II Esophageal Adenocarcinoma AJCC v8
- Clinical Stage III Esophageal Adenocarcinoma AJCC v8
- Clinical Stage III Gastric Cancer AJCC v8
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
- Clinical Stage IV Gastric Cancer AJCC v8
- Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Metastatic Esophageal Adenocarcinoma
- Metastatic Gastric Adenocarcinoma
- Metastatic Gastroesophageal Junction Adenocarcinoma
- Unresectable Esophageal Adenocarcinoma
- Unresectable Gastric Adenocarcinoma
- Unresectable Gastroesophageal Junction Adenocarcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- Participants must have advanced or locally unresectable gastric, gastroesophageal
junction or esophageal adenocarcinoma
- Participants must have PD-L1 CPS (Combined Positive Score) ≥ 1. This test would have
been performed as part of standard of care (SOC) pathology testing, using tissue
obtained within two years prior to registration and collected prior to or after a
frontline regimen
- Participants must have a histologically confirmed diagnosis of microsatellite stable
(MSS) and HER2 negative gastric, gastroesophageal junction, or esophageal
adenocarcinoma
- Participants must have documented unresectable and/or metastatic disease on CT or
MRI imaging completed prior to registration. Imaging must have been completed within
28 days prior to registration for participants with measurable disease. CT scans or
MRIs used to assess non-measurable disease must have been completed within 42 days
prior to registration. All disease must be assessed and documented on the Baseline
Tumor Assessment Form
- Participants with treated brain metastases must have no evidence of progression on
the follow-up brain imaging after central nervous system (CNS)-directed therapy. All
treatment for brain metastases must have been completed at least 28 days prior to
registration
- Participants must have disease progression or intolerance to frontline standard of
care (SOC) chemotherapy plus either nivolumab, pembrolizumab or any other PD-1 or
PD-L1 inhibitor. Peri-operative chemotherapy plus nivolumab, pembrolizumab or any
other PD-1 or PD-L1 inhibitor will count as one line if disease progression occurs
while on the therapy or within 6 months of completing the chemotherapy plus
nivolumab or pembrolizumab or other PD-1/PD-L1 inhibitor cycle
- Participants must not have received more than one prior line of systemic therapy
- Participants must not have a condition requiring systemic treatment with either
corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive
medications within 14 days of registration. Inhaled or topical steroids and adrenal
replacement doses < 10 mg daily prednisone equivalents are permitted in the absence
of active autoimmune disease. Participants are permitted to use topical, ocular,
intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic
absorption). Physiologic replacement doses of systemic corticosteroids are
permitted, even if < 10 mg/day prednisone equivalents. A brief course of
corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of
non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by
contact allergen) is permitted, as long as there has been a washout period for
corticosteroids of ≥ 7 days prior to registration
- Participants must not have prior significant immunotherapy related adverse events
requiring permanent discontinuation of the immunotherapy agent including events like
pneumonitis, myocarditis, renal failure, Guillain barre syndrome, or myasthenia
gravis. Participants with endocrinopathy events leading or not to replacement
steroids, thyroid hormone, insulin, or cortisol are eligible
- Participants must not have received a live attenuated vaccination within 28 days
prior to registration
- Participants must not have had a major surgery within 28 days or subcutaneous venous
access device placement within 7 days prior registration
- Participants must have fully recovered from the effects of prior surgery in the
opinion of the treating investigator. Any participants with postoperative bleeding
complications or wound complications from a surgical procedure performed in the last
eight weeks should be excluded
- Participants must not have plans to undergo elective or planned major surgery during
the clinical trial
- Participants must not have active bleeding or prior history of gastrointestinal (GI)
perforation, fistula or significant GI bleeding (requiring transfusion, endoscopic
or surgical intervention) within 84 days prior to registration
- Participants must not be planning to receive any concurrent chemotherapy,
immunotherapy, investigational agents, biologic or hormonal therapy for cancer
treatment while receiving treatment on this study
- Participants must not have a history of a grade 3 or 4 allergic reaction attributed
to humanized or human monoclonal antibody therapy
- Participants must not have a history of grade 3 or 4 immunotherapy related
toxicities with the exception of hormonal abnormalities like thyroiditis or thyroid
derangements
- Participants must be ≥ 18 years old
- Participants must have Zubrod Performance Status of 0-2
- Participants must have a complete medical history and physical exam within 28 days
prior to registration
- Leukocytes ≥ 2 x 10^3/uL (within 28 days prior to registration)
- Absolute neutrophil count ≥ 1.2 x 10^3/uL (within 28 days prior to registration)
- Hemoglobin ≥ 9.0 g/dL (within 28 days prior to registration)
- Platelets ≥ 100 x 10^3/uL (within 28 days prior to registration)
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days
prior to registration) unless history of Gilbert's disease. Participants with
history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional
ULN (within 28 days prior to registration) (unless liver metastases are present, in
which case they must be ≤ 5 x ULN)
- Participants must have a creatinine ≤ 1.5 x the institutional ULN OR calculated
creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This
specimen must have been drawn and processed within 28 days prior to registration
- Participants' urinary protein must be ≤ 1+ on dipstick or routine urinalysis (UA)
within 28 days of registration. Random analysis of urine protein with a normal value
is sufficient. If urine dipstick or routine analysis indicated proteinuria ≥ 2+,
then a 24-hour urine is to be collected and demonstrate < 1000 mg of protein in 24
hours to allow participation in the study
- Participants must have adequate cardiac function. Participants with known history or
current symptoms of cardiac disease, or history of treatment with cardiotoxic
agents, must have a clinical risk assessment of cardiac function using the New York
Heart Association Functional Classification. To be eligible for this trial,
participants must be class 2 or better
- Participants must have recovered to baseline or < grade 2 CTCAE version (v) 5.0 from
toxicities related to any prior treatments, unless AE(s) are clinically stable on
supportive therapy
- Participants must not have experienced arterial thromboembolic events, including but
not limited to myocardial infarction, transient ischemic attack, cerebrovascular
accident, or unstable angina, within 6 months prior to registration
- Participants must not have uncontrolled blood pressure within 28 days prior to
registration as determined by the treating investigator
- Participants with known human immunodeficiency virus (HIV)-infection must be on
effective anti-retroviral therapy at registration and have undetectable viral load
on the most recent test results obtained within 6 months prior to registration
- Participants with evidence of chronic hepatitis B virus (HBV) infection must have
undetectable HBV viral load while on suppressive therapy on the most recent test
results obtained within 6 months prior to registration, if indicated
- Participants with a history of hepatitis C virus (HCV) infection must have been
treated and cured. Participants currently being treated for HCV infection must have
undetectable HCV viral load on the most recent test results obtained within 6 months
prior to registration, if indicated
- Participants must not have a prior or concurrent malignancy whose natural history or
treatment (in the opinion of the treating physician) has the potential to interfere
with the safety or efficacy assessment of the investigational regimen
- Participants must not be pregnant or nursing (nursing includes breast milk fed to an
infant by any means, including from the breast, milk expressed by hand, or pumped).
Individuals who are of reproductive potential must have agreed to use an effective
contraceptive method with details provided as a part of the consent process. A
person who has had menses at any time in the preceding 12 consecutive months or who
has semen likely to contain sperm is considered to be of "reproductive potential."
In addition to routine contraceptive methods, "effective contraception" also
includes refraining from sexual activity that might result in pregnancy and surgery
intended to prevent pregnancy (or with a side-effect of pregnancy prevention)
including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion,
and vasectomy with testing showing no sperm in the semen
- Participants must not have a history of inflammatory bowel disease, (including
ulcerative colitis and Crohn's disease), symptomatic autoimmune 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). Note: Participants with Graves' disease will
be allowed
- Participants must not have a history of pneumonitis that has required oral or IV
steroids within the last 12 months prior to registration
- Participants must be offered the opportunity to participate in specimen banking.
With participant consent, specimens must be collected and submitted via the
Southwest Oncology Group (SWOG) Specimen Tracking System
- Participants who can complete patient reported outcomes (FACT-Ga and PRO-CTCAE)
questionnaires in English or Spanish must participate in the quality of life studies
- Participants must be informed of the investigational nature of this study and must
sign and give informed consent in accordance with institutional and federal
guidelines. For participants with impaired decision-making capabilities, legally
authorized representatives may sign and give informed consent on behalf of study
participants in accordance with applicable federal, local, and Central Institutional
Review Board (CIRB) regulations
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1 (nivolumab, ramucirumab, paclitaxel) |
Patients receive nivolumab IV over 30 minutes on day 1 of each cycle, ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle, and paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. Patients may also optionally undergo blood sample collection on study. |
|
|
Active Comparator Arm 2 (ramucirumab, paclitaxel) |
Patients receive ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle and paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. Patients may also optionally undergo blood sample collection on study. |
|
Recruiting Locations
Little Rock 4119403, Arkansas 4099753 72205
Site Public Contact
501-202-4715
Little Rock 4119403, Arkansas 4099753 72205
Site Public Contact
501-686-8274
Anaheim 5323810, California 5332921 92806
Baldwin Park 5325866, California 5332921 91706
Bellflower 5327422, California 5332921 90706
Dublin 5344157, California 5332921 94568
Site Public Contact
877-642-4691
Fontana 5349755, California 5332921 92335
Fremont 5350734, California 5332921 94538
Fresno 5350937, California 5332921 93720
Harbor City 5355325, California 5332921 90710
Irvine 5359777, California 5332921 92618
La Jolla 5363943, California 5332921 92093
Los Angeles 5368361, California 5332921 90020
Site Public Contact
213-388-0908
Los Angeles 5368361, California 5332921 90027
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Site Public Contact
323-865-0451
Los Angeles 5368361, California 5332921 90034
Los Angeles 5368361, California 5332921 90048
Site Public Contact
310-423-8965
Modesto 5373900, California 5332921 95356
Newport Beach 5376890, California 5332921 92663
Site Public Contact
323-865-0451
Oakland 5378538, California 5332921 94611
Ontario 5379439, California 5332921 91761
Panorama City 5380932, California 5332921 91402
Riverside 5387877, California 5332921 92505
Roseville 5388881, California 5332921 95661
Sacramento 5389489, California 5332921 95814
Sacramento 5389489, California 5332921 95817
Site Public Contact
916-734-3089
Sacramento 5389489, California 5332921 95823
San Diego 5391811, California 5332921 92120
San Francisco 5391959, California 5332921 94115
San Jose 5392171, California 5332921 95119
San Leandro 5392263, California 5332921 94577
San Marcos 5392368, California 5332921 92078
San Rafael 5392567, California 5332921 94903
Santa Clara 5393015, California 5332921 95051
Santa Rosa 5393287, California 5332921 95403
South San Francisco 5397765, California 5332921 94080
Vallejo 5405380, California 5332921 94589
Walnut Creek 5406990, California 5332921 94596
Woodland Hills 5410438, California 5332921 91367
Colorado Springs 5417598, Colorado 5417618 80909
Site Public Contact
719-365-2406
Colorado Springs 5417598, Colorado 5417618 80920
Site Public Contact
719-364-6700
Fort Collins 5577147, Colorado 5417618 80524
Site Public Contact
970-297-6150
Fort Collins 5577147, Colorado 5417618 80528
Greeley 5577592, Colorado 5417618 80631
Loveland 5579368, Colorado 5417618 80538
Site Public Contact
970-203-7083
Derby 4832745, Connecticut 4831725 06418
Fairfield 4834157, Connecticut 4831725 06824
Glastonbury 4835003, Connecticut 4831725 06033
Greenwich 4835395, Connecticut 4831725 06830
Guilford 4835512, Connecticut 4831725 06437
Hartford 4835797, Connecticut 4831725 06105
New Haven 4839366, Connecticut 4831725 06520
North Haven 4839704, Connecticut 4831725 06473
Stamford 4843564, Connecticut 4831725 06902
Torrington 4844309, Connecticut 4831725 06790
Trumbull 4844459, Connecticut 4831725 06611
Waterbury 4845193, Connecticut 4831725 06708
Waterford 8480031, Connecticut 4831725 06385
Millville 4143696, Delaware 4142224 19967
Newark 4143861, Delaware 4142224 19713
Newark 4143861, Delaware 4142224 19713
Rehoboth Beach 4144284, Delaware 4142224 19971
Washington D.C. 4140963, District of Columbia 4138106 20007
Site Public Contact
202-444-2223
Orlando 4167147, Florida 4155751 32803
Atlanta 4180439, Georgia 4197000 30308
Site Public Contact
888-946-7447
Atlanta 4180439, Georgia 4197000 30322
Site Public Contact
404-778-1868
Atlanta 4180439, Georgia 4197000 30342
Site Public Contact
404-851-7115
Decatur 4191124, Georgia 4197000 30033
Johns Creek 6331909, Georgia 4197000 30097
Honolulu 5856195, Hawaii 5855797 96813
Honolulu 5856195, Hawaii 5855797 96813
Site Public Contact
808-532-0315
Honolulu 5856195, Hawaii 5855797 96813
Site Public Contact
808-545-8548
Honolulu 5856195, Hawaii 5855797 96813
Site Public Contact
808-522-4333
Honolulu 5856195, Hawaii 5855797 96817
Site Public Contact
808-531-8521
Honolulu 5856195, Hawaii 5855797 96819
Honolulu 5856195, Hawaii 5855797 96826
Site Public Contact
808-983-6090
‘Aiea 5856430, Hawaii 5855797 96701
‘Ewa Beach 5855051, Hawaii 5855797 96706
Boise 5586437, Idaho 5596512 83706
Caldwell 5587698, Idaho 5596512 83605
Coeur d'Alene 5589173, Idaho 5596512 83814
Nampa 5601933, Idaho 5596512 83687
Post Falls 5604353, Idaho 5596512 83854
Sandpoint 5606401, Idaho 5596512 83864
Aurora 4883817, Illinois 4896861 60504
Aurora 4883817, Illinois 4896861 60506
Barrington 4884116, Illinois 4896861 60010
Site Public Contact
847-842-4847
Bloomington 4885164, Illinois 4896861 61704
Canton 4831990, Illinois 4896861 61520
Carthage 4886716, Illinois 4896861 62321
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60612
Site Public Contact
312-355-3046
Chicago 4887398, Illinois 4896861 60625
Site Public Contact
773-878-8200
Chicago 4887398, Illinois 4896861 60637
Chicago 4887398, Illinois 4896861 60657
Site Public Contact
773-296-5360
Crystal Lake 4889229, Illinois 4896861 60014
Danville 4889426, Illinois 4896861 61832
Decatur 4236895, Illinois 4896861 62526
Decatur 4236895, Illinois 4896861 62526
DeKalb 4889553, Illinois 4896861 60115
Dixon 4889959, Illinois 4896861 61021
Site Public Contact
815-285-7800
Downers Grove 4890119, Illinois 4896861 60515
Effingham 4237727, Illinois 4896861 62401
Effingham 4237727, Illinois 4896861 62401
Elgin 4890864, Illinois 4896861 60123
Site Public Contact
847-429-2907
Eureka 4891310, Illinois 4896861 61530
Evanston 4891382, Illinois 4896861 60201
Site Public Contact
847-570-2109
Galesburg 4893392, Illinois 4896861 61401
Geneva 4893591, Illinois 4896861 60134
Glenview 4893886, Illinois 4896861 60026
Site Public Contact
847-570-2109
Glenview 4893886, Illinois 4896861 60026
Site Public Contact
312-695-1102
Grayslake 4894465, Illinois 4896861 60030
Site Public Contact
312-695-1102
Hazel Crest 4895416, Illinois 4896861 60429
Site Public Contact
708-799-9995
Highland Park 4895876, Illinois 4896861 60035
Site Public Contact
847-570-2109
Kewanee 4898433, Illinois 4896861 61443
Lake Forest 4899012, Illinois 4896861 60045
Libertyville 4899739, Illinois 4896861 60048
Libertyville 4899739, Illinois 4896861 60048
Macomb 4900817, Illinois 4896861 61455
Mattoon 4244099, Illinois 4896861 61938
New Lenox 4903535, Illinois 4896861 60451
O'Fallon 4245926, Illinois 4896861 62269
Oak Lawn 4904365, Illinois 4896861 60453-2699
Site Public Contact
800-323-8622
Orland Park 4904937, Illinois 4896861 60462
Orland Park 4904937, Illinois 4896861 60462
Ottawa 4905006, Illinois 4896861 61350
Park Ridge 4905367, Illinois 4896861 60068
Site Public Contact
847-384-3621
Pekin 4905599, Illinois 4896861 61554
Peoria 4905687, Illinois 4896861 61615
Peru 4905770, Illinois 4896861 61354
Princeton 4906818, Illinois 4896861 61356
Rockford 4907959, Illinois 4896861 61114
Shiloh 4249910, Illinois 4896861 62269
Springfield 4250542, Illinois 4896861 62702
Site Public Contact
217-545-7929
Springfield 4250542, Illinois 4896861 62702
Site Public Contact
800-444-7541
Springfield 4250542, Illinois 4896861 62781
Urbana 4914570, Illinois 4896861 61801
Warrenville 4915525, Illinois 4896861 60555
Washington 4915545, Illinois 4896861 61571
Crown Point 4919451, Indiana 4921868 46307
Site Public Contact
219-310-2550
Crown Point 4919451, Indiana 4921868 46307
Dyer 4919820, Indiana 4921868 46311
Site Public Contact
219-924-8178
Hobart 4921476, Indiana 4921868 46342
Site Public Contact
219-947-1795
Hobart 4921476, Indiana 4921868 46342
Indianapolis 4259418, Indiana 4921868 46312
Munster 4924014, Indiana 4921868 46321
Site Public Contact
219-836-3349
Munster 4924014, Indiana 4921868 46321
Valparaiso 4927537, Indiana 4921868 46383
Ankeny 4846960, Iowa 4862182 50023
Site Public Contact
515-241-3305
Carroll 4850478, Iowa 4862182 51401
Cedar Rapids 4850751, Iowa 4862182 52403
Site Public Contact
319-365-4673
Cedar Rapids 4850751, Iowa 4862182 52403
Site Public Contact
319-363-2690
Des Moines 4853828, Iowa 4862182 50309
Site Public Contact
515-241-6727
Des Moines 4853828, Iowa 4862182 50309
Site Public Contact
515-241-3305
Des Moines 4853828, Iowa 4862182 50314
Site Public Contact
515-282-2200
Fort Dodge 4857486, Iowa 4862182 50501
Waukee 4880981, Iowa 4862182 50263
Site Public Contact
515-241-3305
Hays 4272782, Kansas 4273857 67601
Site Public Contact
785-623-5774
Lawrence 4274277, Kansas 4273857 66044
Olathe 4276614, Kansas 4273857 66061
Salina 4278890, Kansas 4273857 67401
Topeka 4280539, Kansas 4273857 66606
Site Public Contact
785-295-8000
Lexington 4297983, Kentucky 6254925 40509
New Orleans 4335045, Louisiana 4331987 70121
Cumberland 4352681, Maryland 4361885 21502
Site Public Contact
240-964-1400
Ann Arbor 4984247, Michigan 5001836 48106
Brighton 4986994, Michigan 5001836 48114
Brighton 4986994, Michigan 5001836 48114
Canton 4987990, Michigan 5001836 48188
Canton 4987990, Michigan 5001836 48188
Chelsea 4988628, Michigan 5001836 48118
Chelsea 4988628, Michigan 5001836 48118
Clinton Township 4989133, Michigan 5001836 48038
Detroit 4990729, Michigan 5001836 48202
Escanaba 4992232, Michigan 5001836 49829
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Flint 4992982, Michigan 5001836 48503
Jackson 4997384, Michigan 5001836 49201
Lansing 4998830, Michigan 5001836 48912
Livonia 4999837, Michigan 5001836 48154
Novi 5004062, Michigan 5001836 48374
Novi 5004062, Michigan 5001836 48377
Pontiac 5006166, Michigan 5001836 48341
Southfield 5010636, Michigan 5001836 48075
West Bloomfield 7259621, Michigan 5001836 48322
Ypsilanti 5015688, Michigan 5001836 48197
Bemidji 5017822, Minnesota 5037779 56601
Brainerd 5019116, Minnesota 5037779 56401
Coon Rapids 5022025, Minnesota 5037779 55433
Deer River 5024099, Minnesota 5037779 56636
Duluth 5024719, Minnesota 5037779 55805
Edina 5025264, Minnesota 5037779 55435
Hibbing 5030005, Minnesota 5037779 55746
Site Public Contact
218-786-3308
Minneapolis 5037649, Minnesota 5037779 55407
Saint Louis Park 5045021, Minnesota 5037779 55416
Saint Paul 5045360, Minnesota 5037779 55101
Saint Paul 5045360, Minnesota 5037779 55102
Sandstone 5045908, Minnesota 5037779 55072
Virginia 5051468, Minnesota 5037779 55792
Cape Girardeau 4379966, Missouri 4398678 63703
City of Saint Peters 4407237, Missouri 4398678 63376
Creve Coeur 4382837, Missouri 4398678 63141
Kansas City 4393217, Missouri 4398678 64108
Site Public Contact
816-404-4375
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63129
St Louis 4407066, Missouri 4398678 63136
Billings 5640350, Montana 5667009 59101
Billings 5640350, Montana 5667009 59102
Site Public Contact
800-648-6274
Bozeman 5641727, Montana 5667009 59715
Great Falls 5655240, Montana 5667009 59405
Kalispell 5660340, Montana 5667009 59901
Missoula 5666639, Montana 5667009 59804
Bellevue 5063805, Nebraska 5073708 68123
Omaha 5074472, Nebraska 5073708 68118
Site Public Contact
402-559-5600
Omaha 5074472, Nebraska 5073708 68198
Henderson 5505411, Nevada 5509151 89052
Las Vegas 5506956, Nevada 5509151 89102
Las Vegas 5506956, Nevada 5509151 89148
Reno 5511077, Nevada 5509151 89502
Cherry Hill 4501198, New Jersey 5101760 08002
Englewood 5097672, New Jersey 5101760 07631
Site Public Contact
201-894-3456
Sewell 4504048, New Jersey 5101760 08080
Albuquerque 5454711, New Mexico 5481136 87102
Albuquerque 5454711, New Mexico 5481136 87106
Buffalo 5110629, New York 5128638 14263
Glens Falls 5118693, New York 5128638 12801
Site Public Contact
518-926-6700
Mineola 5127134, New York 5128638 11501
New York 5128581, New York 5128638 10016
Rochester 5134086, New York 5128638 14642
Site Public Contact
585-275-5830
Asheboro 4453035, North Carolina 4482348 27205
Burlington 4458228, North Carolina 4482348 27215
Clinton 4461101, North Carolina 4482348 28328
Goldsboro 4468261, North Carolina 4482348 27534
Greensboro 4469146, North Carolina 4482348 27403
Greensboro 4469146, North Carolina 4482348 27410
Jacksonville 4473083, North Carolina 4482348 28546
Pinehurst 4485272, North Carolina 4482348 28374
Bismarck 5688025, North Dakota 5690763 58501
Fargo 5059163, North Dakota 5690763 58103
Fargo 5059163, North Dakota 5690763 58122
Fargo 5059163, North Dakota 5690763 58122
Centerville 4508204, Ohio 5165418 45459
Cincinnati 4508722, Ohio 5165418 45220
Dayton 4509884, Ohio 5165418 45409
Dayton 4509884, Ohio 5165418 45409
Site Public Contact
937-276-8320
Dayton 4509884, Ohio 5165418 45415
Franklin 4512203, Ohio 5165418 45005-1066
Greenville 5156493, Ohio 5165418 45331
Site Public Contact
937-569-7515
Troy 5174358, Ohio 5165418 45373
Lawton 4540737, Oklahoma 4544379 73505
Site Public Contact
877-231-4440
Oklahoma City 4544349, Oklahoma 4544379 73104
Tulsa 4553433, Oklahoma 4544379 74146
Site Public Contact
918-505-3200
Newberg 5742726, Oregon 5744337 97132
Ontario 5744166, Oregon 5744337 97914
Oregon City 5744253, Oregon 5744337 97045
Portland 5746545, Oregon 5744337 97213
Portland 5746545, Oregon 5744337 97225
Portland 5746545, Oregon 5744337 97239
Allentown 5178127, Pennsylvania 6254927 18103
Bethlehem 5180225, Pennsylvania 6254927 18017
Danville 5186327, Pennsylvania 6254927 17822
East Stroudsburg 5188075, Pennsylvania 6254927 18301
Erie 5188843, Pennsylvania 6254927 16505
Greensburg 5192029, Pennsylvania 6254927 15601
Site Public Contact
724-838-1900
Harrisburg 5192726, Pennsylvania 6254927 17109
Hazleton 5193011, Pennsylvania 6254927 18201
Lancaster 5197079, Pennsylvania 6254927 17601
Lewisburg 5197842, Pennsylvania 6254927 17837
Mechanicsburg 5200657, Pennsylvania 6254927 17050
Monroeville 5201734, Pennsylvania 6254927 15146
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19114
Pittsburgh 5206379, Pennsylvania 6254927 15215
Site Public Contact
412-784-4900
Pittsburgh 5206379, Pennsylvania 6254927 15232
Site Public Contact
412-647-8073
Pittsburgh 5206379, Pennsylvania 6254927 15237
Site Public Contact
412-367-6454
Pittsburgh 5206379, Pennsylvania 6254927 15243
Site Public Contact
412-502-3920
Scranton 5211303, Pennsylvania 6254927 18510
Seneca 5211432, Pennsylvania 6254927 16346
Site Public Contact
814-676-7900
Uniontown 4561859, Pennsylvania 6254927 15401
Wilkes-Barre 5219488, Pennsylvania 6254927 18711
Willow Grove 5219619, Pennsylvania 6254927 19090
Westerly 5225631, Rhode Island 5224323 02891
Charleston 4574324, South Carolina 4597040 29401
Rapid City 5768233, South Dakota 5769223 57701
Sioux Falls 5231851, South Dakota 5769223 57104
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Nashville 4644585, Tennessee 4662168 37232
Site Public Contact
800-811-8480
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Site Public Contact
713-873-2000
Farmington 5774662, Utah 5549030 84025
Salt Lake City 5780993, Utah 5549030 84106
Salt Lake City 5780993, Utah 5549030 84112
Berlin Corners 5233780, Vermont 5242283 05602
Site Public Contact
802-225-5400
Burlington 5234372, Vermont 5242283 05401
Burlington 5234372, Vermont 5242283 05405
Richmond 4781708, Virginia 6254928 23235
Richmond 4781708, Virginia 6254928 23298
Antigo 5244010, Wisconsin 5279468 54409
Ashland 5244247, Wisconsin 5279468 54806
Burlington 5247214, Wisconsin 5279468 53105
Cudahy 5249871, Wisconsin 5279468 53110
Eau Claire 5251436, Wisconsin 5279468 54701
Germantown 5254218, Wisconsin 5279468 53022
Grafton 5254739, Wisconsin 5279468 53024
Green Bay 5254962, Wisconsin 5279468 54301
Green Bay 5254962, Wisconsin 5279468 54303
Green Bay 5254962, Wisconsin 5279468 54311
Kenosha 5258393, Wisconsin 5279468 53142
Madison 5261457, Wisconsin 5279468 53705
Site Public Contact
608-256-1901
Madison 5261457, Wisconsin 5279468 53718
Madison 5261457, Wisconsin 5279468 53792
Marinette 5261852, Wisconsin 5279468 54143
Medford 5262475, Wisconsin 5279468 54451
Milwaukee 5263045, Wisconsin 5279468 53209
Milwaukee 5263045, Wisconsin 5279468 53215
Milwaukee 5263045, Wisconsin 5279468 53233
Minocqua 5263156, Wisconsin 5279468 54548
Mukwonago 5263965, Wisconsin 5279468 53149
Oconomowoc 5265499, Wisconsin 5279468 53066
Site Public Contact
262-928-7878
Oconto Falls 5265522, Wisconsin 5279468 54154
Oshkosh 5265838, Wisconsin 5279468 54904
Racine 5268249, Wisconsin 5279468 53406
Rhinelander 5268720, Wisconsin 5279468 54501
Sheboygan 5272893, Wisconsin 5279468 53081
Sheboygan 5272893, Wisconsin 5279468 53081
Sheboygan 5272893, Wisconsin 5279468 53081
Stevens Point 5274644, Wisconsin 5279468 54481
Sturgeon Bay 5274867, Wisconsin 5279468 54235-1495
Summit, Wisconsin 5279468 53066
Two Rivers 5276609, Wisconsin 5279468 54241
Waukesha 5278052, Wisconsin 5279468 53188
Site Public Contact
262-928-7632
Waukesha 5278052, Wisconsin 5279468 53188
Wausau 5278120, Wisconsin 5279468 54401
Site Public Contact
877-405-6866
Wauwatosa 5278159, Wisconsin 5279468 53226
West Allis 5278420, Wisconsin 5279468 53227
Wisconsin Rapids 5279436, Wisconsin 5279468 54494
Site Public Contact
715-422-7718
More Details
- NCT ID
- NCT06203600
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Detailed Description
PRIMARY OBJECTIVES: I. To assess whether progression-free survival (PFS) is sufficiently improved in participants randomized to nivolumab + paclitaxel + ramucirumab compared to those randomized to paclitaxel + ramucirumab to warrant a phase III study with overall survival (OS) as the primary endpoint. (Phase II) II. To compare OS in participants randomized to nivolumab + paclitaxel + ramucirumab versus those randomized to paclitaxel + ramucirumab. (Phase III) SECONDARY OBJECTIVES: I. To compare PFS between those randomized to nivolumab + paclitaxel + ramucirumab versus those randomized to paclitaxel + ramucirumab. (Phase III) II. To compare OS between participants randomized to nivolumab + paclitaxel + ramucirumab compared to those randomized to paclitaxel + ramucirumab in the event that the trial is completed before the phase III portion. III. To compare the overall response rate (ORR, including confirmed and unconfirmed, complete, and partial response, according to Response Evaluation Criteria in Solid Tumors [RECIST 1.1] criteria) between those randomized to nivolumab + paclitaxel + ramucirumab compared to those randomized to paclitaxel + ramucirumab among participants with measurable disease. IV. To compare the overall disease control rate (DCR = ORR + stable disease) between those randomized to nivolumab + paclitaxel + ramucirumab compared to those randomized to paclitaxel + ramucirumab among participants with measurable disease. V. To evaluate the safety and tolerability of each treatment regimen. VI. To compare health-related quality of life (QOL) by treatment arm at 8 weeks after randomization, measured using the Functional Assessment of Cancer Therapy - Gastric (FACT-Ga) Trial Outcome Index (TOI). VII. To compare health-related QOL between treatment arms at 8 weeks after randomization using the FACT-Ga total score. VIII. To compare longitudinal changes in health-related QOL between treatment arms using FACT-Ga TOI up to 24 weeks after randomization. IX. To compare patient-reported symptoms using selected Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) items including gastrointestinal as well as constitutional symptoms of fatigue, anorexia, and weight loss between treatment arms. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle, ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle, and paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and magnetic resonance imaging (MRI) throughout the study. Patients may also optionally undergo blood sample collection on study. ARM 2: Patients receive ramucirumab IV over 30-60 minutes on days 1 and 15 of each cycle and paclitaxel IV over 60 minutes on days 1, 8 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI throughout the study. Patients may also optionally undergo blood sample collection on study. After completion of study treatment, patients are followed up at 30, 60, 90 days and then every 6 months for up to 3 years.