Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Pembrolizumab

Albumin-Bound Paclitaxel

Immunomodulating Agents

Ramucirumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Pembrolizumab will be administered every 3 weeks in combination with ramucirumab + paclitaxel. The paclitaxel schedule differs between the 2 arms.

Pembrolizumab Monotherapy

Harry H Yoon, MD, MHS

Ahran Lee

Wendy Ferguson

Harry Yoon, MD

Stacey Zindars, MS

Ben George, MD

Cohort 1 \[CLOSED\] Study treatment involves two segments: (1) Induction Immunotherapy segment with pembrolizumab monotherapy every 3 weeks until irRECIST PD and (2) Combination Therapy segment. Nab-paclitaxel may be utilized in place of paclitaxel at investigator's discretion for subjects with paclitaxel reactions.

Cohort 2 Patients are randomized to Arm A or B. Treatment in both arms includes pembrolizumab + RAM + paclitaxel.

Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma

Phase 2 Study of Novel SEQUEnced Immunotherapy (Pembrolizumab) With Anti-angiogenesis and Chemotherapy in Advanced Gastric and gastroesophageaL Junction (GEJ) Adenocarcinoma

BORR is defined as the number of best responses (including rates of complete response \[CR\], partial response \[PR\], disease control \[DCR\], stable disease \[SD\], progressive disease \[PD\]) divided by the total number of evaluable patients. Evaluate the BORR of combined ramucirumab (RAM) plus paclitaxel (with differing schedules of pembrolizumab \[PEM\]) following induction of PEM in patients with advanced gastric and GEJ adenocarcinoma pooling Arm A and B.

PFS is defined as the time from the date of randomization to the first documented disease progression or death due to all causes, whichever occurs first. Evaluate PFS of combined ramucirumab (RAM) plus paclitaxel plus pembrolizumab (PEM) in patients with advanced gastric and GEJ adenocarcinoma with prior exposure to immunotherapy, within Arm A and Arm B separately.

BORR (including rates of complete response \[CR\], partial response \[PR\], disease control \[DCR\], stable disease \[SD\], progressive disease \[PD\]).

Duration of overall response-the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started).

irPFS is defined as time from randomization until documented progression per irRECIST

Overall survival defined date of randomization until date of death from any cause

PFS is defined as time from randomization until documented progression per RECIST

Spots Global Cancer Trial Database for Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma

Trial Identification

Conditions

Interventions

Study Description

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