NCT07195682

Brief Summary

This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone or in combination by participants with ccRCC.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for phase_1

Timeline
54mo left

Started Jan 2026

Longer than P75 for phase_1

Geographic Reach
5 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Apr 2031

First Submitted

Initial submission to the registry

September 25, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2030

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2031

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

4.3 years

First QC Date

September 25, 2025

Last Update Submit

August 7, 2026

Conditions

Renal Cell Carcinoma

Keywords

Metastatic clear cell renal cell carcinomaAdvanced clear cell renal cell carcinomaccRCCKidney cancer

Outcome Measures

Primary Outcomes (5)

  • Number of Participants With Adverse Events (AEs)

    Up to approximately 2 years from first dose of BMS-986506

  • Number of Participants With Serious Adverse Events (SAEs)

    Up to approximately 2 years from first dose of BMS-986506

  • Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria

    Up to approximately Day 28

  • Number of Participants With AEs Leading to Discontinuation

    Up to approximately 2 years from first dose of BMS-986506

  • Number of Participants With AEs Leading to Deaths as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0

    Up to approximately 2 years from first dose of BMS-986506

Secondary Outcomes (7)

  • Maximum Observed Plasma Concentration (Cmax) of BMS-986506

    Up to approximately Day 85

  • Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506

    Up to approximately Day 112

  • Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506

    Up to approximately Day 112

  • Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Up to approximately 3 years from first dose of BMS-986506

  • Disease Control Rate (DCR) as Assessed by RECIST v1.1

    Up to approximately 3 years from first dose of BMS-986506

  • +2 more secondary outcomes

Study Arms (7)

Part 1A BMS-986506 Monotherapy Escalation

EXPERIMENTAL
Drug: BMS-986506

Part 2A BMS-986506 Monotherapy Expansion

EXPERIMENTAL
Drug: BMS-986506

Part 2B BMS-986506 Monotherapy Expansion

EXPERIMENTAL
Drug: BMS-986506

Part 3A BMS-986506 + Pumitamig Combination Dose Escalation

EXPERIMENTAL
Drug: BMS-986506Drug: Pumitamig

Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Escalation

EXPERIMENTAL
Drug: BMS-986506Drug: PumitamigDrug: Ipilimumab

Part 4A BMS-986506 + Pumitamig Combination Dose Expansion

EXPERIMENTAL
Drug: BMS-986506Drug: Pumitamig

Part 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion

EXPERIMENTAL
Drug: BMS-986506Drug: PumitamigDrug: Ipilimumab

Interventions

BMS-986506DRUG

Specified dose on specified days

Part 1A BMS-986506 Monotherapy EscalationPart 2A BMS-986506 Monotherapy ExpansionPart 2B BMS-986506 Monotherapy ExpansionPart 3A BMS-986506 + Pumitamig Combination Dose EscalationPart 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose EscalationPart 4A BMS-986506 + Pumitamig Combination Dose ExpansionPart 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion
PumitamigDRUG

Specified dose on specified days

Also known as: BMS-986545, BNT327, PM8002
Part 3A BMS-986506 + Pumitamig Combination Dose EscalationPart 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose EscalationPart 4A BMS-986506 + Pumitamig Combination Dose ExpansionPart 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion
IpilimumabDRUG

Specified dose on specified days

Also known as: Yervoy, BMS-734016
Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose EscalationPart 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.
  • For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.
  • For part 2: Participants must have had at least one standard treatment plan that included both a PD-1/L1 inhibitor and a VEGF-TKI (either together or one after the other).
  • Part 3: Participants must have had at least 1 standard treatment regimen (including a PD-1/L1 checkpoint inhibitor and/or a VEGF-TKI).
  • Part 4: Participants must not have received prior systemic therapy for metastatic RCC, but may have received prior adjuvant therapy for completely resected RCC with PD-1 inhibitor if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.
  • Eastern Cooperative Oncology Group performance status of 0 to 1.

You may not qualify if:

  • Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.
  • Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.
  • Part 2A and Part 4: Participants who have received prior treatment with belzutifan (or another HIF2a inhibitor).
  • Part 3B and Part 4B: Participants who have received prior ipilimumab (or another anti-CTLA-4 containing antibody).
  • Participants who have hypoxia as defined by a pulse oximeter reading \< 92% at rest or requires intermittent or chronic supplemental oxygen.
  • Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.
  • Part 3 and Part 4: Participants with a history of Grade ≥3 immune-mediated AEs leading to discontinuation of prior immunotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

Gustave Roussy

Villejuif, Val-de-Marne, 94800, France

RECRUITING

Local Institution - 0031

Roma, 00168, Italy

NOT YET RECRUITING

Local Institution - 0033

Verona, 37134, Italy

NOT YET RECRUITING

Hospital Universitario Reina Sofia

Córdoba, Andalusia, 14004, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Renal CellClear-cell metastatic renal cell carcinomaKidney Neoplasms

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2025

First Posted

September 29, 2025

Study Start

January 15, 2026

Primary Completion (Estimated)

May 3, 2030

Study Completion (Estimated)

April 3, 2031

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations

US(5)FR(1)CA(1)ES(2)IT(2)