Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

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Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Nivolumab

TIC10 compound

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Cola

625mg ONC201 Cycle 1 Day -7 dose then once week

500 mg ONC201 Cycle 1 Day -7 dose then once week

375 mg ONC201 Cycle 1 Day -7 dose then once week

ONC201 625mg + Nivolumab 240mg IV flat dose

Dose level 1 ONC201 625mg

ONC201 500mg + Nivolumab 240mg IV flat dose

Dose level 2 ONC201 500mg

ONC201 375mg + Nivolumab 240mg IV flat dose

Dose level 3 ONC201 375mg

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.

This is a single arm study of de-escalating arms to determine the MTD and then expand the trial.It is not randomized.

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

BrUOG 379: A Phase Ib/II Single Arm Study of ONC201 Plus Nivolumab in Microsatellite Stable (MSS) Metastatic Colorectal Cancer (mCRC) Patients

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Rhode Island Hospital

Bristol-Myers Squibb

Oncoceutics, Inc.

Brown University

625mg ONC201 Cycle 1 Day -7 dose then once week

Dose level 1 ONC201 625mg: ONC201 625mg + Nivolumab 240mg IV flat dose

ONC201 Level 1 (Starting Dose Level)

500 mg ONC201 Cycle 1 Day -7 dose then once week

Dose level 2 ONC201 500mg: ONC201 500mg + Nivolumab 240mg IV flat dose

ONC201 Level 2

375 mg ONC201 Cycle 1 Day -7 dose then once week

Dose level 3 ONC201 375mg: ONC201 375mg + Nivolumab 240mg IV flat dose

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
BrUOG 379 Phase Ib/II Trial ONC201 + Nivolumab in MSS mCRC	NCT03791398	Metastatic Colo...	Dose level 1 ON... Dose level 2 ON... Dose level 3 ON...	18 Years -	Brown University
BrUOG 379 Phase Ib/II Trial ONC201 + Nivolumab in MSS mCRC	NCT03791398	Metastatic Colo...	Dose level 1 ON... Dose level 2 ON... Dose level 3 ON...	18 Years -	Brown University

Spots Global Cancer Trial Database for dose level 1 onc201 625mg