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BrUOG 379 Phase Ib/II Trial ONC201 + Nivolumab in MSS mCRC

NCT03791398 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-02-17

Study results available
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Summary

This is a single arm Phase Ib/II, open label, safety, pharmacokinetic, pharmacodynamics and efficacy study of ONC201 in combination with Opdivo (Nivolumab) in adult patients with metastatic colorectal cancer, for whom no standard therapy is available. This study will enroll adult patients with metastatic colorectal cancer who progressed after at least two lines of therapy.

Conditions

Interventions

DRUG

Dose level 1 ONC201 625mg

ONC201 625mg + Nivolumab 240mg IV flat dose

DRUG

Dose level 2 ONC201 500mg

ONC201 500mg + Nivolumab 240mg IV flat dose

DRUG

Dose level 3 ONC201 375mg

ONC201 375mg + Nivolumab 240mg IV flat dose

Sponsors & Collaborators

  • Rhode Island Hospital

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Oncoceutics, Inc.

    collaborator INDUSTRY

  • Brown University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2021-06-16
Completion
2021-08-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03791398 on ClinicalTrials.gov