Actively Recruiting
A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)
Led by Bristol-Myers Squibb · Updated on 2026-05-13
234
Participants Needed
72
Research Sites
295 weeks
Total Duration
On this page
Sponsors
B
Bristol-Myers Squibb
Lead Sponsor
B
BioNTech SE
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with Ipilimumab or Cabozantinib in participants with advanced Renal Cell Carcinoma (RCC)
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced or metastatic Renal Cell Carcinoma (RCC) not suitable for curative surgery or radiation
- Clear cell RCC or non-clear cell RCC (Part 1); Part 2 only enrolls clear cell RCC
- Disease categorized as favorable, intermediate, or poor risk
- No prior systemic therapy for metastatic RCC except specific allowed prior treatments
- Measurable disease according to RECIST v1.1
You will not qualify if you...
- Untreated known central nervous system metastases
- Need for systemic corticosteroids (> 10 mg prednisone daily) or other immunosuppressants within 14 days before treatment start
- History of interstitial lung disease or pneumonitis
- Uncontrolled pleural or pericardial effusion requiring repeated drainage
- Significant cardiovascular disease within 6 months before treatment
- Uncontrolled hypertension despite treatment
- Congenital long QT syndrome
- Urine protein ≥ 2+ and 24-hour urine protein ≥ 1 g at baseline
- Major coagulation disorders
- History of deep vein thrombosis, pulmonary embolism, or major thromboembolism within 6 months
- History of abdominal fistula or gastrointestinal perforation within 6 months
- Major surgery or trauma within 28 days prior to treatment start
- Other protocol-defined inclusion/exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 72 locations
1
Local Institution - 0117
New Haven, Connecticut, United States, 06510
Not Yet Recruiting
2
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
3
Local Institution - 0126
Orlando, Florida, United States, 32803
Not Yet Recruiting
4
Local Institution - 0124
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
5
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
6
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Local Institution - 0096
Hauppauge, New York, United States, 11788
Not Yet Recruiting
8
Local Institution - 0135
Cincinnati, Ohio, United States, 45219
Not Yet Recruiting
9
Local Institution - 0127
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
10
MUSC Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
11
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
12
Local Institution - 0158
Salt Lake City, Utah, United States, 84112
Withdrawn
13
Local Institution - 0095
Seattle, Washington, United States, 98109-1023
Not Yet Recruiting
14
Local Institution - 0154
Buenos Aires, Argentina, 1426
Not Yet Recruiting
15
Local Institution - 0156
Buenos Aires, Argentina, C1199ABB
Not Yet Recruiting
16
Local Institution - 0076
North Ryde, New South Wales, Australia, 2109
Not Yet Recruiting
17
GenesisCare St Leonards
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
18
Local Institution - 0074
South Brisbane, Queensland, Australia, 4101
Not Yet Recruiting
19
Local Institution - 0003
Malvern, Australia, 3144
Not Yet Recruiting
20
Local Institution - 0093
Brasília, Federal District, Brazil, 70200-730
Not Yet Recruiting
21
Local Institution - 0007
Calgary, Alberta, Canada, T2N 4N2
Not Yet Recruiting
22
Local Institution - 0109
Montreal, Quebec, Canada, H2L 4M1
Not Yet Recruiting
23
Local Institution - 0009
Montreal, Quebec, Canada, H3T 1E2
Not Yet Recruiting
24
Local Institution - 0105
Santiago, Santiago Metropolitan, Chile, 7510032
Not Yet Recruiting
25
Bradfordhill
Santiago, Santiago Metropolitan, Chile, 8420383
Actively Recruiting
26
Local Institution - 0163
Santiago, Chile, 8330023
Not Yet Recruiting
27
Local Institution - 0052
Cali, Colombia, 760032
Not Yet Recruiting
28
Local Institution - 0147
Prague, Praha 5, Czechia, 150 06
Not Yet Recruiting
29
Local Institution - 0149
Brno, Czechia, 656 53
Not Yet Recruiting
30
Local Institution - 0150
Hradec Králové, Czechia, 500 05
Not Yet Recruiting
31
Local Institution - 0044
Helsinki, Etelä-Suomen Lääni, Finland, 00290
Not Yet Recruiting
32
Local Institution - 0029
Turku, Finland, 20521
Not Yet Recruiting
33
Local Institution - 0060
Vantaa, Finland, 01640
Not Yet Recruiting
34
Local Institution - 0083
Lille, Nord, France, 59020
Not Yet Recruiting
35
Local Institution - 0080
Boredeaux, France, 33076
Not Yet Recruiting
36
Local Institution - 0028
Villejuif, France, 94805
Not Yet Recruiting
37
Local Institution - 0025
Jena, Thuringia, Germany, 07747
Not Yet Recruiting
38
Local Institution - 0026
Hamburg, Germany, 20251
Not Yet Recruiting
39
Local Institution - 0014
Herne, Germany, 44649
Not Yet Recruiting
40
Local Institution - 0027
München, Germany, 81675
Not Yet Recruiting
41
Local Institution - 0059
Dublin, Ireland, D07 R2WY
Not Yet Recruiting
42
Local Institution - 0062
Dublin, Ireland, D24 NR0A
Not Yet Recruiting
43
Local Institution - 0139
Verona, Veneto, Italy, 37126
Not Yet Recruiting
44
Local Institution - 0073
Milan, Italy, 20133
Not Yet Recruiting
45
Local Institution - 0087
Napoli Campania, Italy, 80131
Not Yet Recruiting
46
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
47
Local Institution - 0078
Toyoma, Toyama, Japan, 930-0194
Not Yet Recruiting
48
Local Institution - 0172
Fukuoka, Japan, 812-8582
Not Yet Recruiting
49
Local Institution - 0046
Monterrey, Nuevo León, Mexico, 64040
Not Yet Recruiting
50
Local Institution - 0048
Oaxaca City, Mexico, 68020
Not Yet Recruiting
51
Local Institution - 0122
Puebla City, Mexico, 72424
Not Yet Recruiting
52
Local Institution - 0049
Tlalpan, Mexico, 14080
Not Yet Recruiting
53
Local Institution - 0108
Tlalpan, Mexico, 14080
Not Yet Recruiting
54
Local Institution - 0118
Tlalpan, Mexico, 14080
Not Yet Recruiting
55
Local Institution - 0103
Cluj-Napoca, Romania, 400015
Not Yet Recruiting
56
Local Institution - 0161
Craiova, Romania, 200347
Not Yet Recruiting
57
Local Institution - 0100
Iași, Romania, 700483
Not Yet Recruiting
58
Local Institution - 0101
Sibiu, Romania, 550082
Not Yet Recruiting
59
Local Institution - 0112
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
Not Yet Recruiting
60
Local Institution - 0017
Seoul, Seoul-teukbyeolsi, South Korea, 05505
Not Yet Recruiting
61
Local Institution - 0167
Seoul, South Korea, 120-752
Not Yet Recruiting
62
Local Institution - 0013
Madrid, Spain, 28041
Not Yet Recruiting
63
Local Institution - 0091
Madrid, Spain, 28050
Not Yet Recruiting
64
Local Institution - 0043
Seville, Spain, 41013
Not Yet Recruiting
65
Kantonsspital Graubünden
Chur, Switzerland, 7000
Actively Recruiting
66
HOCH Health Ostschweiz
Sankt Gallen, Switzerland, 9007
Actively Recruiting
67
UniversitätsSpital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
68
Royal Marsden Hospital (Chelsea)
London, Kensington and Chelsea, United Kingdom, SW3 6JJ
Actively Recruiting
69
St Bartholomew's Hospital
London, London, City of, United Kingdom, EC1A 7BE
Actively Recruiting
70
Local Institution - 0057
Cardiff, United Kingdom, CF14 2TL
Not Yet Recruiting
71
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
72
Royal Marsden Hospital Sutton
Sulton, Surrey, United Kingdom, SM25PT
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here