Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial

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 Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo optional blood sample collection
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Nivolumab — BIOLOGICAL
  Given IV
• Paclitaxel — DRUG
  Given IV
• Questionnaire Administration — OTHER
  Ancillary studies
• Ramucirumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Jun 24, 2024

Status verified

Feb 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

224 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Progression free survival (PFS) (Phase II) [ Time Frame: From date of randomization to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 3 years ]

Locations (371)

Find similar trials in Little Rock, AR

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