An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment

Phase 1

Completed

• Conditions: Advanced Cancer
• Interventions: Biological: Nivolumab; Biological: Ipilimumab; Drug: IDO1 Inhibitor; Biological: Relatlimab; Biological: Cabiralizumab; Radiation: Radiation Therapy

• Registration Number: NCT03335540
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the treatment of solid tumors with various immunotherapy combinations. The treatment will be determined based upon a broad biomarker assessment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-07
• Study Start: 2018-05-07
• Primary Completion: 2021-03-31
• Study Completion: 2021-08-25
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Participants must have an ECOG performance status of less than or equal to 1
• Participants must have had prior therapy;Participants who have received adjuvant or neoadjuvant anti-PD(L)1 therapy andprogressed within 6 months of completing therapy will be considered IO refractory.
• Participants must have at least 2 lesions with measurable disease as defined by RECIST Version 1.1

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Exclusion Criteria

• Participants with suspected, known, or progressive CNS metastases, have untreated CNS metastases, or have the CNS as the only site of disease
• Participants with carcinomatous meningitis
• Participants with other active malignancy requiring concurrent intervention

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm D	Ipilimumab	Combination therapy determined by biomarker assessment
Arm F	Nivolumab	Combination therapy determined by biomarker assessment
Arm F	IDO1 Inhibitor	Combination therapy determined by biomarker assessment
Arm B	Relatlimab	Combination therapy determined by biomarker assessment
Arm C	Nivolumab	Combination therapy determined by biomarker assessment
Arm C	Cabiralizumab	Combination therapy determined by biomarker assessment
Arm G	Nivolumab	Combination therapy determined by biomarker assessment
Arm G	Radiation Therapy	Combination therapy determined by biomarker assessment
Arm B	Nivolumab	Combination therapy determined by biomarker assessment
Arm D	Nivolumab	Combination therapy determined by biomarker assessment

Primary Outcome Measures

Name	Time	Method
Number of participants with qualified tumor biopsy specimen at baseline	Up to 28 days	An adequate quality tumor biopsy providing sufficient information prior to choosing a combination immunotherapy/Stereotactic Body Radiation Therapy (SBRT)

Secondary Outcome Measures

Name	Time	Method
Percent of change from baseline in histopathologic features	Up to 4 years
Percent of change from baseline in biomarker expression patterns	Up to 4 years
Number of Serious Adverse Events (SAEs)	Up to 4 years
Number of Adverse Events(AEs) leadind to discontinutaion	up to 4 years	Number of Adverse Events leadind to discontinutaion
Number of Adverse Events (AEs)	Up to 4 years
Number of Laboratory Abnormalities	Up to 4 years	Any laboratory test result that is clinically significant or meets the definition of an SAE, requires the participant to have study treatment discontinued, or receive specific corrective therapy
Number of Deaths	up to 4 years

Trial Locations

Locations (4)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0001; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0003; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0002; 🇺🇸 Baltimore, Maryland, United States