A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A)
- Conditions
- Colorectal CancerBiliary Tract CancerPancreatic Ductal Adenocarcinoma
- Interventions
- Biological: Sacituzumab tirumotecanDrug: Fluorouracil (5-FU)Drug: Leucovorin (LV) or levoleucovorinDrug: Rescue medicationDrug: Supportive care measures
- Registration Number
- NCT06428409
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with chemotherapy can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:
* About the safety and how well people tolerate sacituzumab tirumotecan alone or with chemotherapy
* How many people have the cancer respond (get smaller or go away) to treatment
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
The main inclusion criteria include but are not limited to the following:
-
Has one of the following cancers:
- Unresectable or metastatic colorectal cancer
- Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
- Advanced and/or unresectable biliary tract cancer (BTC)
-
Has received prior therapy for the cancer
-
Has recovered from any side effects due to previous cancer treatment
The main exclusion criteria include but are not limited to the following:
- History of severe eye disease
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sacituzumab tirumotecan + Chemotherapy Fluorouracil (5-FU) Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy by intravenous (IV) infusion, every 2 weeks. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment. Sacituzumab tirumotecan + Chemotherapy Leucovorin (LV) or levoleucovorin Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy by intravenous (IV) infusion, every 2 weeks. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment. Sacituzumab tirumotecan + Chemotherapy Sacituzumab tirumotecan Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy by intravenous (IV) infusion, every 2 weeks. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment. Sacituzumab tirumotecan + Chemotherapy Rescue medication Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy by intravenous (IV) infusion, every 2 weeks. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment. Sacituzumab tirumotecan + Chemotherapy Supportive care measures Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy by intravenous (IV) infusion, every 2 weeks. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment. Sacituzumab tirumotecan Sacituzumab tirumotecan Participants will receive sacituzumab tirumotecan every 2 weeks via IV infusion. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate the treatment. Sacituzumab tirumotecan Rescue medication Participants will receive sacituzumab tirumotecan every 2 weeks via IV infusion. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate the treatment. Sacituzumab tirumotecan Supportive care measures Participants will receive sacituzumab tirumotecan every 2 weeks via IV infusion. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate the treatment.
- Primary Outcome Measures
Name Time Method Number of Participants Who Experience a Dose-limiting Toxicity (DLT) Up to approximately 4 weeks A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. DLTs will be measured during Cycle 1 (the first 4 weeks) of treatment.
Number of Participants Who Experience One or More Adverse Events (AEs): Up to approximately 53 months An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.
Number of Participants who Discontinue Study Treatment due to an AE Up to approximately 53 months An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) Up to approximately 53 months ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
- Secondary Outcome Measures
Name Time Method Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR Up to approximately 53 months PFS is defined as the time from start of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. According to RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR Up to approximately 53 months For participants who demonstrate a confirmed Complete Response or Partial Response, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Overall Survival (OS) Up to approximately 53 months OS is the length of time from when the participant starts treatment until death from any cause
Trial Locations
- Locations (41)
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
🇺🇸Mineola, New York, United States
One Clinical Research ( Site 0002)
🇦🇺Nedlands, Western Australia, Australia
University of Florida College of Medicine ( Site 0281)
🇺🇸Gainesville, Florida, United States
Mount Sinai Cancer Center ( Site 0287)
🇺🇸Miami Beach, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
🇺🇸Marietta, Georgia, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
🇺🇸New York, New York, United States
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
🇺🇸Roanoke, Virginia, United States
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
🇺🇸Madison, Wisconsin, United States
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
🇦🇺Brisbane, Queensland, Australia
Frankston Hospital-Oncology and Haematology ( Site 0004)
🇦🇺Frankston, Victoria, Australia
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)
🇨🇦Montréal, Quebec, Canada
James Lind Centro de Investigacion del Cancer ( Site 0048)
🇨🇱Temuco, Araucania, Chile
FALP-UIDO ( Site 0041)
🇨🇱Providencia, Region M. De Santiago, Chile
Clínica UC San Carlos de Apoquindo ( Site 0043)
🇨🇱Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 0047)
🇨🇱Santiago, Region M. De Santiago, Chile
Beijing Cancer hospital-Digestive Oncology ( Site 0061)
🇨🇳Beijing, Beijing, China
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si
🇨🇳Fuzhou, Fujian, China
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0064)
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital-intervention department ( Site 0066)
🇨🇳Changsha, Hunan, China
West China Hospital, Sichuan University ( Site 0068)
🇨🇳Cheng Du, Sichuan, China
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
🇮🇹Milan, Lombardia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)
🇮🇹Roma, Italy
National Cancer Center Hospital East ( Site 0121)
🇯🇵Kashiwa, Chiba, Japan
Kanagawa cancer center ( Site 0122)
🇯🇵Yokohama, Kanagawa, Japan
Seoul National University Hospital ( Site 0161)
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System ( Site 0164)
🇰🇷Seoul, Korea, Republic of
Asan Medical Center ( Site 0163)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center ( Site 0162)
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)
🇪🇸Oviedo, Asturias, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)
🇪🇸Barcelona, Spain
Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
🇨🇭Genève, Geneve, Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 0201)
🇨🇭Bellinzona, Ticino, Switzerland
China Medical University Hospital ( Site 0223)
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)
🇨🇳Tainan, Taiwan
National Taiwan University Hospital-Oncology ( Site 0225)
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital ( Site 0221)
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0222)
🇨🇳Taoyuan, Taiwan
Barts Health NHS Trust ( Site 0263)
🇬🇧London, England, United Kingdom
Royal Free Hospital ( Site 0262)
🇬🇧London, England, United Kingdom
University Hospital Coventry & Warwickshire ( Site 0266)
🇬🇧Coventry, United Kingdom