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A Study to Assess the Safety and Tolerability of BMS-986527 in Participants With Clear Cell Renal Cell Carcinoma (ccRCC)

ConditionClear Cell Renal Cell Carcinoma (ccRCC)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

About this trial

The purpose of this study is to assess the safety and tolerability of BMS-986527 in participants with Clear Cell Renal Cell Carcinoma (ccRCC)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic renal cell carcinoma (RCC) with clear cell component.

Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Participants must have measurable disease as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

For Cohorts 1 and 2, participants should have previously received, be refractory to, ineligible for, or intolerant of standard of care (SoC) immunotherapy (IO) and/or tyrosine kinase inhibitors (TKIs). Participants in Cohort 3 should have previously received, be refractory to, ineligible for, or intolerant of SoC IO, but those who have not been previously exposed to SoC TKI agents are permitted.

Disqualifiers

Participants must not have prior history of malignancies (other than clear cell renal cell carcinoma (ccRCC)) or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years.

For Cohort 2 only: has relapsed or is refractory within 12 months of the most recent IO therapy.

For Cohort 3 only: use of strong inhibitor and inducers of CYP3A4, and P-glycoprotein (P-gp) substrates within 14 days or 5 half-lives (whichever is longer) of start of TKI.

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Design model

Single group

Treatments tested in this trial

  • BMS-986527

    Drug

    Specified dose on specified days

  • Nivolumab

    Drug

    Specified dose on specified days

  • Cabozantinib

    Drug

    Specified dose on specified days

Treatment groups

112 Participants
are divided into 3 treatment groups
Group A: Cohort 1: BMS-986527 monotherapyExperimental treatment 1 intervention
Group B: Cohort 2: BMS-986527 with NivolumabExperimental treatment 2 interventions
Group C: Cohort 3: BMS-986527 with CabozantinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

Time frame
Up to 2 years
2

Incidence of serious adverse events (SAEs)

Time frame
Up to 2 years
3

Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

Time frame
Up to 2 years
4

Incidence of AEs leading to discontinuation

Time frame
Up to 2 years

Secondary outcomes

1

Overall response rate (ORR)

Time frame
Up to 2 years
2

Complete response rate (CRR)

Time frame
Up to 2 years
3

Disease control rate (DCR)

Time frame
Up to 2 years
4

Duration of response (DOR)

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Lead sponsor

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: