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Study of Pembrolizumab With Pemetrexed and Oxaliplatin in Chemo-Refractory Metastatic Colorectal Cancer Patients

NCT03626922 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-06-10

No results posted yet for this study

Summary

This is a Phase Ib study to evaluate the safety and preliminary anti-tumor activity of pembrolizumab in combination with pemetrexed with or without oxaliplatin in patients with chemo-refractory microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without any further standard treatment options.

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV on Day 1 of each 21 day cycle until maximum of 35 cycles.

DRUG

Pemetrexed

Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle until maximum of 35 cycles.

DRUG

Oxaliplatin

Oxaliplatin-Dose level1: 85 mg/m2 IV on Day 1 of each 21 day cycle until a maximum of 35 cycles or until discontinued due to patient election, toxicity, disease progression. Dose level 2: 120 mg/m2 IV on Day 1 of each 21 day cycle until a maximum of 35 cycles or until discontinued due to patient election, toxicity, disease progression. The MTD dose of oxaliplatin in the study combination of Cohort 2 will be the recommended Phase II dose (RP2D) for the cohort expansion.

DRUG

Dexamethasone

Dexamethasone-4 mg by mouth twice daily on: the day before, the day of, and the day after each dose of pemetrexed.

DIETARY_SUPPLEMENT

Folic Acid

Folic Acid-400 micrograms by mouth daily starting 5 days prior to first dose of pemetrexed and continue daily to include 21 days after the last dose of pemetrexed.

DIETARY_SUPPLEMENT

Vitamin B-12

1000 micrograms administered intramuscularly 7 days prior to the first dose of pemetrexed, every 9 weeks, and should continue until 3 weeks after the last dose of pemetrexed.

Sponsors & Collaborators

Principal Investigators

  • Norman Wolmark, MD · NSABP Foundation Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2021-10-31
Completion
2022-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03626922 on ClinicalTrials.gov