Clinical trial · Interventional
An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment
ADaptiVe Biomarker Trial That InformS Evolution of Therapy
NCT03335540CI-TRIAL-00061037ADVISEcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabiralizumab | Biological | — | UNRESOLVED |
| IDO1 Inhibitor | Drug | — | UNRESOLVED |
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Relatlimab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Combination therapy determined by biomarker assessment
- interventionNames
- Biological: Nivolumab
- Biological: Relatlimab
- type
- EXPERIMENTAL
- label
- Arm C
- description
- Combination therapy determined by biomarker assessment
- interventionNames
- Biological: Nivolumab
- Biological: Cabiralizumab
- type
- EXPERIMENTAL
- label
- Arm D
- description
- Combination therapy determined by biomarker assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLuke JJ, Bever K, Hodi FS, Taube J, Massey A, Yao D, Neely J, Tam R, Lee G, Gupta A, Dutta S, Szabo P, Bao R, Reilly T. Rationale and feasibility of a rapid integral biomarker program that informs immune-oncology clinical trials: the ADVISE trial. J Immunother Cancer. 2025 May 19;13(5):e011170. doi: 10.1136/jitc-2024-011170. PMID 40389374