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

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ClinicalTrials.gov Identifier: NCT03791398

Recruitment Status : Terminated (Lack of efficacy)

First Posted : January 2, 2019

Results First Posted : June 21, 2022

Last Update Posted : February 17, 2023

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Rhode Island Hospital

Bristol-Myers Squibb

Oncoceutics, Inc.

Information provided by (Responsible Party):

Brown University

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Metastatic Colorectal Cancer
Interventions	Drug: Dose level 1 ONC201 625mg Drug: Dose level 2 ONC201 500mg Drug: Dose level 3 ONC201 375mg
Enrollment	13

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	ONC201 Level 1 (Starting Dose Level)	ONC201 Level 2	ONC201 Level 3
Arm/Group Description	625mg ONC201 Cycle 1 Day -7 dose th...	500 mg ONC201 Cycle 1 Day -7 dose t...	375 mg ONC201 Cycle 1 Day -7 dose t...
Arm/Group Description	625mg ONC201 Cycle 1 Day -7 dose then once week Dose level 1 ONC201 625mg: ONC201 625mg + Nivolumab 240mg IV flat dose	500 mg ONC201 Cycle 1 Day -7 dose then once week Dose level 2 ONC201 500mg: ONC201 500mg + Nivolumab 240mg IV flat dose	375 mg ONC201 Cycle 1 Day -7 dose then once week Dose level 3 ONC201 375mg: ONC201 375mg + Nivolumab 240mg IV flat dose
Period Title: Overall Study
Started	13	0	0
Completed	11	0	0
Not Completed	2	0	0
Reason Not Completed
Progression of Disease Under Study	2	0	0

Baseline Characteristics

Arm/Group Title		ONC201 Level 1 (Starting Dose Level)	ONC201 Level 2	ONC201 Level 3	Total
Arm/Group Description		625mg ONC201 Cycle 1 Day -7 dose th...	500 mg ONC201 Cycle 1 Day -7 dose t...	375 mg ONC201 Cycle 1 Day -7 dose t...	Total of all reporting groups
Arm/Group Description		625mg ONC201 Cycle 1 Day -7 dose then once week Dose level 1 ONC201 625mg: ONC201 625mg + Nivolumab 240mg IV flat dose	500 mg ONC201 Cycle 1 Day -7 dose then once week Dose level 2 ONC201 500mg: ONC201 500mg + Nivolumab 240mg IV flat dose	375 mg ONC201 Cycle 1 Day -7 dose then once week Dose level 3 ONC201 375mg: ONC201 375mg + Nivolumab 240mg IV flat dose	Total of all reporting groups
Overall Number of Baseline Participants		13	0	0	13
Baseline Analysis Population Description		...
Baseline Analysis Population Description		No patients were enrolled to dose level 2 or 3.
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	13 participants	0 participants	0 participants	13 participants
	<=18 years	0 0.0%			0 0.0%
	Between 18 and 65 years	8 61.5%			8 61.5%
	>=65 years	5 38.5%			5 38.5%
Age, Continuous Mean (Full Range) Unit of measure: Years
	Number Analyzed	13 participants	0 participants	0 participants	13 participants
		60 (34 to 84)			60 (34 to 84)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	13 participants	0 participants	0 participants	13 participants
	Female	8 61.5%			8 61.5%
	Male	5 38.5%			5 38.5%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	13 participants	0 participants	0 participants	13 participants
	Hispanic or Latino	1 7.7%			1 7.7%
	Not Hispanic or Latino	12 92.3%			12 92.3%
	Unknown or Not Reported	0 0.0%			0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	13 participants	0 participants	0 participants	13 participants
	American Indian or Alaska Native	0 0.0%			0 0.0%
	Asian	1 7.7%			1 7.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%			0 0.0%
	Black or African American	3 23.1%			3 23.1%
	White	9 69.2%			9 69.2%
	More than one race	0 0.0%			0 0.0%
	Unknown or Not Reported	0 0.0%			0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	13 participants	0 participants	0 participants	13 participants
United States		13			13

Outcome Measures

1.Primary Outcome


Title	Maximum Tolerated Dose of ONC201 With Nivolumab for Phase II
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Cycle 1 (each cycle is approximately 4 weeks) through pre-dosing cycle 2, approximately 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	ONC201 Level 1 (Starting Dose Level)
Arm/Group Description:	625mg ONC201 Cycle 1 Day -7 dose th...
Arm/Group Description:	625mg ONC201 Cycle 1 Day -7 dose then once week Dose level 1 ONC201 625mg: ONC201 625mg + Nivolumab 240mg IV flat dose
Overall Number of Participants Analyzed	11
Measure Type: Number Unit of Measure: mg
	625

2.Primary Outcome


Title	Progression Free Survival
Description	Progression is defined using Response Evaluation Criteria In Solid Tum...
Description	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.
Time Frame	From start of protocol therapy until death or progression, a maximum of 6 months from end of therapy.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	ONC201 Level 1 (Starting Dose Level)
Arm/Group Description:	625mg ONC201 Cycle 1 Day -7 dose th...
Arm/Group Description:	625mg ONC201 Cycle 1 Day -7 dose then once week Dose level 1 ONC201 625mg: ONC201 625mg + Nivolumab 240mg IV flat dose
Overall Number of Participants Analyzed	11
Mean (Full Range) Unit of Measure: days
	58 (9 to 97)

Adverse Events

Time Frame	All adverse events were collected from the time a signed and dated ICF is obtained until 100 days (+1 week) after the last treatment (Nivolumab or ONC201, whichever is last), or until the subject withdraws consent from study participation or at the time patient becomes a screen failure, whichever occurs first. An average of 6 months.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	ONC201 Level 1 (Starting Dose Level)
Arm/Group Description	625mg ONC201 Cycle 1 Day -7 dose th...
Arm/Group Description	625mg ONC201 Cycle 1 Day -7 dose then once week Dose level 1 ONC201 625mg: ONC201 625mg + Nivolumab 240mg IV flat dose
All-Cause Mortality
	ONC201 Level 1 (Starting Dose Level)
	Affected / at Risk (%)
Total	11/13 (84.62%)
Serious Adverse Events Serious Adverse Events
	ONC201 Level 1 (Starting Dose Level)
	Affected / at Risk (%)
Total	10/13 (76.92%)
Gastrointestinal disorders
Small intestinal obstruction ^* 1	4/13 (30.77%)
Abdominal pain ^* 1	1/13 (7.69%)
Constipation ^* 1	1/13 (7.69%)
Pancreatitis ^* 1	1/13 (7.69%)
General disorders
Disease progression ^* 1	8/13 (61.54%)
Hepatobiliary disorders
Biliary obstruction ^* 1	1/13 (7.69%)
Infections and infestations
Fungemia ^* 1	1/13 (7.69%)
Abdominal infection ^* 1	1/13 (7.69%)
Investigations
Blood bilirubin increased ^* 1	1/13 (7.69%)
Musculoskeletal and connective tissue disorders
Back pain ^* 1	1/13 (7.69%)
Neck pain ^* 1	1/13 (7.69%)
Nervous system disorders
Muscle weakness right-sided ^* 1	1/13 (7.69%)
Dizziness ^* 1	1/13 (7.69%)
Renal and urinary disorders
Hematuria ^* 1	1/13 (7.69%)
Surgical and medical procedures
Endoscopic retrograde cholangiopancreatography ^* 1	1/13 (7.69%)
1 Term from vocabulary, CTCAE (5.0) * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	ONC201 Level 1 (Starting Dose Level)
	Affected / at Risk (%)
Total	13/13 (100.00%)
Blood and lymphatic system disorders
Anemia ^* 1	2/13 (15.38%)
Endocrine disorders
Hypothyroidism ^* 1	1/13 (7.69%)
Gastrointestinal disorders
Dry mouth ^* 1	1/13 (7.69%)
Gastritis ^* 1	1/13 (7.69%)
Abdominal cramping ^* 1	1/13 (7.69%)
Vomiting ^* 1	1/13 (7.69%)
General disorders
Edema limbs ^* 1	1/13 (7.69%)
Fatigue ^* 1	5/13 (38.46%)
Investigations
Lipase increased ^* 1	1/13 (7.69%)
Lymphocyte count decreased ^* 1	3/13 (23.08%)
Thyroid stimulating hormone increased ^* 1	2/13 (15.38%)
Weight loss ^* 1	1/13 (7.69%)
Metabolism and nutrition disorders
Anorexia ^* 1	1/13 (7.69%)
Dehydration ^* 1	1/13 (7.69%)
Hyponatremia ^* 1	1/13 (7.69%)
Musculoskeletal and connective tissue disorders
Myalgia ^* 1	1/13 (7.69%)
Nervous system disorders
Dizziness ^* 1	1/13 (7.69%)
Skin and subcutaneous tissue disorders
Hyperhidrosis ^* 1	1/13 (7.69%)
Rash maculo-papular ^* 1	2/13 (15.38%)
Vascular disorders
Hypotension ^* 1	1/13 (7.69%)
1 Term from vocabulary, CTCAE (5.0) * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Brown University Oncology Research Group
Organization:	BrUOG
Phone:	401-863-3000
EMail:	BrUOG@Brown.edu

Layout table for additonal information

Responsible Party:	Brown University
ClinicalTrials.gov Identifier:	NCT03791398
Other Study ID Numbers:	BrUOG 379
First Submitted:	December 26, 2018
First Posted:	January 2, 2019
Results First Submitted:	April 28, 2022
Results First Posted:	June 21, 2022
Last Update Posted:	February 17, 2023

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