Renal Cell CarcinomaPhase 1NCT07195682
A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
A Phase 1 study testing BMS-986506, Pumitamig and Ipilimumab in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 11 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- BMS-986506, Pumitamig and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 15 Jan 2026to 3 Apr 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
11 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
11 sites in 5 countries
United States5 sites, 5 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Stephanie Berg, Site 0006, 617-632-4932
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Benjamin Garmezy, Site 0026, 713-444-7804
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Martin Voss, Site 0029, 646-888-4721
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Elizabeth Plimack, Site 0002, 215-728-3889
- Recruiting
START San Antonio
San Antonio, Texas, 78229
Amita Patnaik, Site 0001, 210-593-5250
Italy2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0031
Roma, 00168
Site 0031
- Not yet recruiting
Local Institution - 0033
Verona, 37134
Site 0033
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Cristina Suarez Rodriguez, Site 0018, 349327460004350
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004
MARIA JOSE MENDEZ VIDAL, Site 0015, +34957011448
Canada1 site, 1 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Daniel Heng, Site 0021, 4035213166
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, Val-de-Marne, 94800
Christophe Massard, Site 0008, +33142114211
About this study
Official title: A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- BMS-986506, Pumitamig, Ipilimumab
- Keywords
- Metastatic clear cell renal cell carcinoma, Advanced clear cell renal cell carcinoma, ccRCC, Kidney cancer
- Medical subject headings
- Carcinoma, Renal Cell, Clear-cell metastatic renal cell carcinoma, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986506Drug
Specified dose on specified days
PumitamigDrug
Also called BMS-986545, BNT327, PM8002
Specified dose on specified days
IpilimumabDrug
Also called Yervoy, BMS-734016
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1A BMS-986506 Monotherapy Escalation | Experimental | Not described Receives: Drug: BMS-986506 |
| Part 2A BMS-986506 Monotherapy Expansion | Experimental | Not described Receives: Drug: BMS-986506 |
| Part 2B BMS-986506 Monotherapy Expansion | Experimental | Not described Receives: Drug: BMS-986506 |
| Part 3A BMS-986506 + Pumitamig Combination Dose Escalation | Experimental | Not described Receives: Drug: BMS-986506; Drug: Pumitamig |
| Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Escalation | Experimental | Not described Receives: Drug: BMS-986506; Drug: Pumitamig; Drug: Ipilimumab |
| Part 4A BMS-986506 + Pumitamig Combination Dose Expansion | Experimental | Not described Receives: Drug: BMS-986506; Drug: Pumitamig |
| Part 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion | Experimental | Not described Receives: Drug: BMS-986506; Drug: Pumitamig; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Measured: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria
Measured: Up to approximately Day 28
Number of Participants With AEs Leading to Discontinuation
Measured: 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
Measured: Up to approximately 2 years from first dose of BMS-986506
Secondary outcomes (7)
Maximum Observed Plasma Concentration (Cmax) of BMS-986506
Measured: Up to approximately Day 85
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506
Measured: Up to approximately Day 112
Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506
Measured: Up to approximately Day 112
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measured: Up to approximately 3 years from first dose of BMS-986506
Disease Control Rate (DCR) as Assessed by RECIST v1.1
Measured: Up to approximately 3 years from first dose of BMS-986506
Duration of Response (DOR) as Assessed by RECIST v1.1
Measured: Up to approximately 3 years from first dose of BMS-986506
Time to Response (TTR) as Assessed by RECIST v1.1
Measured: Up to approximately 3 years from first dose of BMS-986506
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start15 Jan 2026
- Primary completion3 May 2030 (estimated)
- Study completion3 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 281 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195682
- Sponsor's protocol ID
- CA242-0001
- Other IDs
- 2025-522543-18, U1111-1323-5879, 2025
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
- ClinicalTrials.gov ID
- NCT07195682
- Acronym / sponsor ID
- CA242-0001
- Conditions
- Renal Cell Carcinoma
- Keywords
- Metastatic clear cell renal cell carcinoma, Advanced clear cell renal cell carcinoma, ccRCC, Kidney cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 281 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 3 May 2030 (estimated)
- Study completion
- 3 Apr 2031 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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-986506, Drug: Pumitamig |
| Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Escalation | Experimental | Drug: BMS-986506, Drug: Pumitamig, Drug: Ipilimumab |
| Part 4A BMS-986506 + Pumitamig Combination Dose Expansion | Experimental | Drug: BMS-986506, Drug: Pumitamig |
| Part 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion | Experimental | Drug: BMS-986506, Drug: Pumitamig, Drug: Ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986506Specified dose on specified days | Drug | Part 1A BMS-986506 Monotherapy Escalation, Part 2A BMS-986506 Monotherapy Expansion, Part 2B BMS-986506 Monotherapy Expansion, Part 3A BMS-986506 + Pumitamig Combination Dose Escalation, Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Escalation, Part 4A BMS-986506 + Pumitamig Combination Dose Expansion, Part 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion |
| PumitamigAlso: BMS-986545, BNT327, PM8002Specified dose on specified days | Drug | Part 3A BMS-986506 + Pumitamig Combination Dose Escalation, Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Escalation, Part 4A BMS-986506 + Pumitamig Combination Dose Expansion, Part 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion |
| IpilimumabAlso: Yervoy, BMS-734016Specified dose on specified days | Drug | Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Escalation, Part 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to approximately 2 years from first dose of BMS-986506
Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria
Time frame: Up to approximately Day 28
Number of Participants With AEs Leading to Discontinuation
Time frame: 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
Time frame: Up to approximately 2 years from first dose of BMS-986506
7 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of BMS-986506
Time frame: Up to approximately Day 85
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986506
Time frame: Up to approximately Day 112
Area Under the Concentration-time Curve Within a Dosing Interval (AUC-TAU) of BMS-986506
Time frame: Up to approximately Day 112
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Up to approximately 3 years from first dose of BMS-986506
Disease Control Rate (DCR) as Assessed by RECIST v1.1
Time frame: Up to approximately 3 years from first dose of BMS-986506
Duration of Response (DOR) as Assessed by RECIST v1.1
Time frame: Up to approximately 3 years from first dose of BMS-986506
Time to Response (TTR) as Assessed by RECIST v1.1
Time frame: Up to approximately 3 years from first dose of BMS-986506
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986506, Pumitamig and Ipilimumab in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Italy, Spain, Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: Up to approximately 2 years from first dose of BMS-986506). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.