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

Bristol-Myers Squibb (BMS) logo

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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