Trial studying safety and effects for Advanced Renal Cell Carcinoma (RCC)
Official title A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)
ClinicalTrials.gov ID: NCT07293351
What this study is testing
What is Pumitamig?
Pumitamig is an investigational medicine, being studied as a potential treatment for advanced renal cell carcinoma (rcc).
Also referred to as BMS-986545, BNT327.
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 how safe, tolerable, and effective Pumitamig is, either by itself or combined with other treatments, for advanced renal cell carcinoma.
- Who it's for
- Adults who have advanced renal cell carcinoma (kidney cancer).
- What's involved
- Participants will receive Pumitamig, possibly together with other cancer medicines, and will have regular clinic visits and tests to monitor safety and response.
- Phase 2: a mid-size study of how well it works
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 a histologically confirmed diagnosis of locally advanced, unresectable (not amenable to curative surgery or radiation therapy)...
- Participants must have clear cell RCC (ccRCC) or non-clear cell RCC (nccRCC) may be enrolled in Part 1. Note: Part 2 may only enroll participants...
- Participants may have favorable, intermediate or poor risk disease categories.
- Participants must not have received prior systemic therapy for metastatic RCC, with the following exceptions: i) One prior adjuvant or neoadjuvant...
You likely can't join if
- Participants must not have any untreated known CNS metastases.
- Participants must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other...
- Participants must not have a history of interstitial lung disease or pneumonitis.
- Participants must not have an uncontrolled pleural or pericardial effusion requiring recurrent therapeutic drainage procedures.
- Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular...
- Participants must not have a urine protein ≥ 2+ on dipstick or urinalysis at baseline and confirmed proteinuria ≥ 1 g/24 hours or urine...
See the full eligibility criteria
- Participants must have a histologically confirmed diagnosis of locally advanced, unresectable (not amenable to curative surgery or radiation therapy) or metastatic Renal Cell Carcinoma (RCC).
- Participants must have clear cell RCC (ccRCC) or non-clear cell RCC (nccRCC) may be enrolled in Part 1. Note: Part 2 may only enroll participants with ccRCC.
- Participants may have favorable, intermediate or poor risk disease categories.
- Participants must not have received prior systemic therapy for metastatic RCC, with the following exceptions: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed if such therapy did not...
- Participants must not have any untreated known CNS metastases.
- Participants must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of Cycle 1 Day1 (C1D1).
- Participants must not have a history of interstitial lung disease or pneumonitis.
- Participants must not have an uncontrolled pleural or pericardial effusion requiring recurrent therapeutic drainage procedures.
- Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to C1D1, uncontrolled hypertension (≥...
- Participants must not have a urine protein ≥ 2+ on dipstick or urinalysis at baseline and confirmed proteinuria ≥ 1 g/24 hours or urine protein-creatinine ratio (UPCR) \> 1000 mg/g.
- Participants must not have evidence of major coagulation disorders.
- Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 6 months prior to C1D1.
- Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months.
- Participants must not have had a major surgery or trauma within 28 days prior to C1D1.
- For Part 2D and 2E: Receiving ongoing concomitant treatment with sensitive substrates of CYP3A4, CYP2C8, CYP2C9, or CYP2C19 with narrow therapeutic indices within 5 half-lives of the concomitant treatment or up to 28...
- For Part 2D and 2E: Receiving ongoing concomitant treatment with moderate or strong CYP3A4 inducers, or moderate or strong CYP3A4 inhibitors within 5 half-lives of the concomitant treatment, or up to 28 days, whichever...
- For Part 2D and 2E: Has hypoxia defined by a pulse oximeter reading \< 92% at rest or requires intermittent or chronic supplemental oxygen.
- For Part 2D and 2E: Exercise-induced desaturation on a 6-minute walk test, defined as a blood oxygen saturation by pulse oximetry ≤ 88%.
- For Part 2D and 2E: Presence of significant pulmonary disease/condition (eg, chronic obstructive pulmonary disease, pleural effusion, etc) that, in the opinion of the Investigator, could put participant at increased...
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Fort Wayne, Indiana, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Big Rapids, Michigan, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Charleston, South Carolina, United States
- Myrtle Beach, South Carolina, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Buenos Aires, Argentina
- North Ryde, New South Wales, Australia
+ 66 more site(s).
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 Palo Alto, California, United States; New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Orlando, Florida, United States; Fort Wayne, Indiana, United States and 80 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.