A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2
A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2
This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.
Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).
It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.
Inclusion Criteria:
Cohorts A and B
Cohort C
Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
No prior systemic therapy for LA/mUC
At least one measurable lesion by investigator assessment based on RECIST v1.1.
Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample
ECOG performance status of 0, 1, or 2
Cohort D
Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
Based on a participant's eligibility to receive treatment with standard of care therapies in Japan, participants must have received all of the following lines of therapy for LA/mUC:
At least one measurable lesion by investigator assessment based on RECIST v1.1.
ECOG performance status of 0 or 1
Cohort E
Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra
No prior systemic therapy for LA/mUC
At least one measurable lesion by investigator assessment based on RECIST v1.1.
Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
ECOG performance status of 0 or 1
Cohort G
Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra
Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of therapy containing enfortumab vedotin as monotherapy or in combination with pembrolizumab
At least one measurable lesion by investigator assessment based on RECIST version 1.1.
HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Exclusion Criteria:
Cohorts A and B
Cohort C
Cohort D
Cohort E
Cohort G
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
ClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021
Baldwin Park, California 91706, United States
Duarte, California 91010, United States
Irvine, California 92612, United States
Irvine, California 92618, United States
Los Angeles, California 90017, United States
Los Angeles, California 90034, United States
Los Angeles, California 90095, United States
Panorama City, California 91402, United States
Riverside, California 92505, United States
San Diego, California 92108, United States
San Francisco, California 94158, United States
San Gabriel, California 91776, United States
San Luis Obispo, California 93401, United States
Woodland Hills, California 91367, United States
Washington D.C., District of Columbia 20010, United States
N. Venice, Florida 34275, United States
Sarasota, Florida 34239, United States
Carrollton, Georgia 30117, United States
Carrollton, Georgia 30117, United States
Cartersville, Georgia 30121, United States
Douglasville, Georgia 30134, United States
Hiram, Georgia 30141, United States
Marietta, Georgia 30060, United States
New Lenox, Illinois 60451, United States
Orland Park, Illinois 60462, United States
Worcester, Massachusetts 01655, United States
Detroit, Michigan 48202, United States
Farmington Hills, Michigan 48334, United States
Grand Rapids, Michigan 49546, United States
Lansing, Michigan 48910, United States
Long Island City, New York 11101, United States
New York, New York 10021, United States
New York, New York 10065, United States
New York, New York 10065, United States
Chapel Hill, North Carolina 27514, United States
Chapel Hill, North Carolina 27599, United States
Charlotte, North Carolina 28204, United States
Columbus, Ohio 43210, United States
Buenos Aires, Buenos Aires F.D. 1113, Argentina
CABA, C1019ABS, Argentina
Caba, ZC 1426, Argentina
Alexandria, New South Wales 2015, Australia
South Brisbane, Queensland QLD 4101, Australia
Frankston, Victoria 3199, Australia
Vancouver, British Columbia V5Z 1H7, Canada
Sherbrooke, Quebec J1H 5N4, Canada
La Serena, Coquimbo Region 1720430, Chile
Roma, ROME 00168, Italy
Padova, 35128, Italy
Kashiwa-shi, Chiba 277-8577, Japan
Suita-shi, Osaka 565-0871, Japan
Koto-ku, Tokyo 135-8550, Japan
Osaka, 541-8567, Japan
Ankara, 06620, Turkey (Türkiye)
Edirne, 22030, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)
Manchester, M20 4BX, United Kingdom
Merseyside, CH63 4JY, United Kingdom