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, Arkansas 72205
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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.