Health TrialsbyHealthPanel

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

ConditionsAdvanced Esophageal AdenocarcinomaAdvanced Gastric AdenocarcinomaAdvanced Gastroesophageal Junction AdenocarcinomaClinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Gastric Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IV Esophageal Adenocarcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Metastatic Esophageal AdenocarcinomaMetastatic Gastric AdenocarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaUnresectable Esophageal AdenocarcinomaUnresectable Gastric AdenocarcinomaUnresectable Gastroesophageal Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo optional blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Nivolumab

    Biological/Vaccine

    Given IV

  • Paclitaxel

    Drug

    Given IV

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Ramucirumab

    Biological/Vaccine

    Given IV

Treatment groups

224 Participants
are divided into 2 treatment groups
Group A: Arm 1 (nivolumab, ramucirumab, paclitaxel)Experimental treatment 7 interventions
Group B: Arm 2 (ramucirumab, paclitaxel)Active comparator 6 interventions

Trial outcomes

Primary outcomes

1

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.

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
2

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.

Time frame
From date of randomization to date of death due to any cause, assessed up to 3 years

Secondary outcomes

1

Objective response rate (ORR)

Will be compared across arms in participants with measurable disease via Fisher's exact test.

Time frame
Up to 3 years
2

Disease control rate (DCR)

DCR = ORR + stable disease per Response Evaluation Criteria in Solid Tumors 1.1. Will be compared across arms in participants with measurable disease via Fisher's exact test.

Time frame
Up to 3 years
3

Incidence of adverse events

Time frame
Up to 3 years

Other outcomes

1

Disease-free survival (DFS)

The hazard ratio of DFS and the corresponding 95% confidence intervals will be estimated for subgroups defined by sex, race, and ethnicity, respectively.

Time frame
Up to 3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
Apply now