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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer

Treatments: Biological: Cabiralizumab; Biological: Nivolumab; Drug: IDO1 Inhibitor; Biological: Relatlimab; Radiation: Radiation Therapy; Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03335540

CA028-001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 5 patient groups

Arm B

Experimental group

Description:

Combination therapy determined by biomarker assessment

Treatment:

Biological: Relatlimab

Biological: Nivolumab

Arm C

Experimental group

Description:

Combination therapy determined by biomarker assessment

Treatment:

Biological: Nivolumab

Biological: Cabiralizumab

Arm D

Experimental group

Description:

Combination therapy determined by biomarker assessment

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Arm F

Experimental group

Description:

Combination therapy determined by biomarker assessment

Treatment:

Drug: IDO1 Inhibitor

Biological: Nivolumab

Arm G

Experimental group

Description:

Combination therapy determined by biomarker assessment

Treatment:

Radiation: Radiation Therapy

Biological: Nivolumab