Clinical trial for Renal Cell Carcinoma
Official title A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
ClinicalTrials.gov ID: NCT07195682
What this study is testing
What is BMS-986506?
an investigational medicine being studied as a potential treatment for advanced clear cell renal cell carcinoma
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if BMS-986506 is safe and can be tolerated when given alone or with other treatments.
- Who it's for
- Adults who have advanced clear cell renal cell carcinoma.
- What's involved
- Participants will receive BMS-986506, either by itself or together with other cancer medicines, and will have regular safety check‑ups and tests.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
You likely can't join 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...
- 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...
See the full eligibility criteria
- 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...
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Calgary, Alberta, Canada
- Villejuif, Val-de-Marne, France
- Roma, Italy
- Verona, Italy
- Córdoba, Andalusia, Spain
- Barcelona, Barcelona [Barcelona], Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States; San Antonio, Texas, United States; Calgary, Alberta, Canada and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.