NCT06203600|RecruitingPhase 2FDA Drug

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

Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab Versus Paclitaxel + Ramucirumab in Patients With PD-L1 CPS >/= 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2023-11064S2303U10CA180888

Study Type

interventional

Target

224

Locations

1 country

Sites

370

Timeline

RegisteredJan 2024

StartedJun 2024

CompletionOct 2027

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

224

participants targeted

Target at P75+ for phase_2

Timeline

18mo left

Started Jun 2024

Typical duration for phase_2

Geographic Reach

1 country

370 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.4 years study duration

Study Progress56%

Jun 2024Oct 2027

First Submitted

Initial submission to the registry

January 10, 2024

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed

5 months until next milestone

Study Start

First participant enrolled

June 24, 2024

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

May 5, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

January 10, 2024

Last Update Submit

May 2, 2026

Conditions

Advanced Gastric Adenocarcinoma Advanced Gastroesophageal Junction Adenocarcinoma Clinical Stage III Gastric Cancer AJCC v8 Clinical Stage IV Gastric Cancer AJCC v8 Metastatic Esophageal Adenocarcinoma Advanced Esophageal Adenocarcinoma Clinical Stage II Esophageal Adenocarcinoma AJCC v8 Clinical Stage III Esophageal Adenocarcinoma AJCC v8 Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Unresectable Esophageal Adenocarcinoma Unresectable Gastric Adenocarcinoma Clinical Stage IV Esophageal Adenocarcinoma AJCC v8 Unresectable Gastroesophageal Junction Adenocarcinoma Metastatic Gastric Adenocarcinoma Metastatic Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

Progression free survival (PFS) (Phase II)
The distribution of PFS will be estimated using the method of Kaplan-Meier and compared using a 1-sided stratified log-rank test.
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
Overall survival (OS) (Phase III)
The distribution of OS will be estimated using the method of Kaplan-Meier and compared using a 1-sided stratified log-rank test.
From date of randomization to date of death due to any cause, assessed up to 3 years

Secondary Outcomes (3)

Objective response rate (ORR)
Up to 3 years
Disease control rate (DCR)
Up to 3 years
Incidence of adverse events
Up to 3 years

Other Outcomes (1)

Disease-free survival (DFS)
Up to 3 years

Study Arms (2)

Arm 1 (nivolumab, ramucirumab, paclitaxel)

EXPERIMENTAL

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.

Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingBiological: NivolumabDrug: PaclitaxelOther: Questionnaire AdministrationBiological: Ramucirumab

Arm 2 (ramucirumab, paclitaxel)

ACTIVE COMPARATOR

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.

Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingDrug: PaclitaxelOther: Questionnaire AdministrationBiological: Ramucirumab