Trial Title:
A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A)
NCT ID:
NCT06428409
Condition:
Colorectal Cancer
Pancreatic Ductal Adenocarcinoma
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Gastrointestinal Neoplasms
Leucovorin
Fluorouracil
Levoleucovorin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Sacituzumab tirumotecan
Description:
Given by IV infusion every 2 weeks (Day 1 and Day 15 of every 4-week cycle)
Arm group label:
Sacituzumab tirumotecan
Arm group label:
Sacituzumab tirumotecan + Chemotherapy
Other name:
MK-2870
Intervention type:
Drug
Intervention name:
Fluorouracil (5-FU)
Description:
5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks
Arm group label:
Sacituzumab tirumotecan + Chemotherapy
Intervention type:
Drug
Intervention name:
Leucovorin (LV) or levoleucovorin
Description:
LV or levoleucovorin is administered by IV infusion every 2 weeks
Arm group label:
Sacituzumab tirumotecan + Chemotherapy
Intervention type:
Drug
Intervention name:
Rescue medication
Description:
Participants are allowed to take rescue medication to prevent hypersensitivity and/or
infusion reactions as a premedication to study treatment. At the discretion of the
investigator, participants are provided with a prescription for rescue medications.
Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist,
acetaminophen or equivalent, dexamethasone or equivalent infusion. A steroid mouthwash
(dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.
Arm group label:
Sacituzumab tirumotecan
Arm group label:
Sacituzumab tirumotecan + Chemotherapy
Intervention type:
Drug
Intervention name:
Supportive care measures
Description:
Participants are allowed to take supportive care measures for the management of adverse
events associated with study intervention at the discretion of the investigator.
Supportive care measures may include but are not limited to antidiarrheal agents and
antiemetic agents.
Arm group label:
Sacituzumab tirumotecan
Arm group label:
Sacituzumab tirumotecan + Chemotherapy
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
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
Exclusion Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Florida College of Medicine ( Site 0281)
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
352-273-7832
Facility:
Name:
Mount Sinai Cancer Center ( Site 0287)
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
305-674-2625
Facility:
Name:
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
Address:
City:
Marietta
Zip:
30060
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
770-281-5100
Facility:
Name:
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
646-599-4083
Facility:
Name:
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
Address:
City:
Roanoke
Zip:
24014
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
540-982-0237
Facility:
Name:
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
608-265-9966
Facility:
Name:
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
Address:
City:
Brisbane
Zip:
4029
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61736468111
Facility:
Name:
Frankston Hospital-Oncology and Haematology ( Site 0004)
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61425733507
Facility:
Name:
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)
Address:
City:
Montréal
Zip:
H2X 0A9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5148908000
Facility:
Name:
James Lind Centro de Investigacion del Cancer ( Site 0048)
Address:
City:
Temuco
Zip:
4800827
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56994443272
Facility:
Name:
FALP-UIDO ( Site 0041)
Address:
City:
Providencia
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56224457254
Facility:
Name:
Clínica UC San Carlos de Apoquindo ( Site 0043)
Address:
City:
Santiago
Zip:
7620002
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56991290140
Facility:
Name:
Bradfordhill-Clinical Area ( Site 0047)
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56998744662
Facility:
Name:
Beijing Cancer hospital-Digestive Oncology ( Site 0061)
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8601088196340
Facility:
Name:
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0064)
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
86138808640033
Facility:
Name:
West China Hospital, Sichuan University ( Site 0068)
Address:
City:
Cheng Du
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8618980605963
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
390223903807
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
390458128116
Facility:
Name:
National Cancer Center Hospital East ( Site 0121)
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-4-7133-1111
Facility:
Name:
Kanagawa cancer center ( Site 0122)
Address:
City:
Yokohama
Zip:
241-8515
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-45-520-2222
Facility:
Name:
Seoul National University Hospital ( Site 0161)
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82220720701
Facility:
Name:
Severance Hospital, Yonsei University Health System ( Site 0164)
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82222288137
Facility:
Name:
Asan Medical Center ( Site 0163)
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82 2 3010 3945
Facility:
Name:
Samsung Medical Center ( Site 0162)
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+82234103549
Facility:
Name:
Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)
Address:
City:
Oviedo
Zip:
33011
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34646662756
Facility:
Name:
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34914269393
Facility:
Name:
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0034 932 54 34 50
Facility:
Name:
Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
Address:
City:
Genève
Zip:
1211
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
41223729861
Facility:
Name:
Ospedale Regionale Bellinzona e Valli ( Site 0201)
Address:
City:
Bellinzona
Zip:
6500
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
41918118667
Facility:
Name:
China Medical University Hospital ( Site 0223)
Address:
City:
Taichung
Zip:
404332
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+886 4 22052121ext5057
Facility:
Name:
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
886623535354559
Facility:
Name:
National Taiwan University Hospital-Oncology ( Site 0225)
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8862231234567680
Facility:
Name:
Taipei Veterans General Hospital ( Site 0221)
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8862287121212573
Facility:
Name:
Chang Gung Medical Foundation-Linkou Branch ( Site 0222)
Address:
City:
Taoyuan
Zip:
33305
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
886-975368114
Facility:
Name:
Barts Health NHS Trust ( Site 0263)
Address:
City:
London
Zip:
E1 1RD
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
07985955179
Facility:
Name:
University Hospital Coventry & Warwickshire ( Site 0266)
Address:
City:
Coventry
Zip:
CV2 2DX
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
442476967151
Start date:
June 20, 2024
Completion date:
December 3, 2028
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06428409
https://www.merckclinicaltrials.com
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=9999-02A&&kw=9999-02A
