A Clinical Study Of MK-2870 Alone Or With Other Treatments To Treat Gastrointestinal Cancers (MK-9999-02A)

Study Overview

A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments 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 of sacituzumab tirumotecan alone or with other treatments and if people tolerate it * How many people have the cancer respond (get smaller or go away) to treatment

N/A

Colorectal Cancer
Pancreatic Ductal Adenocarcinoma
Biliary Tract Cancer

BIOLOGICAL: Sacituzumab tirumotecan
DRUG: Fluorouracil (5-FU)
DRUG: Leucovorin (LV) or levoleucovorin
DRUG: Rescue medication
DRUG: Supportive care measures
DRUG: Cisplatin
BIOLOGICAL: Pembrolizumab

9999-02A
MK-9999-02A (OTHER Identifier) (OTHER: MSD)
2023-508703-21-00 (REGISTRY Identifier) (REGISTRY: EU CT)
U1111-1298-8273 (REGISTRY Identifier) (REGISTRY: UTN)
jRCT2031240178 (REGISTRY Identifier) (REGISTRY: jRCT)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-05-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-18
First Submitted that Met QC Criteria 2024-05-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-20
First Posted (ACTUAL) 2024-05-24	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Sacituzumab tirumotecan + Chemotherapy Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerat	BIOLOGICAL: Sacituzumab tirumotecan Given by IV infusion. DRUG: Fluorouracil (5-FU) 5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks. DRUG: Leucovorin (LV) or levoleucovorin LV or levoleucovorin is administered by IV infusion every 2 weeks. DRUG: Rescue medication 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. Re DRUG: Supportive care measures 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 a
EXPERIMENTAL: Sacituzumab tirumotecan Participants will receive sacituzumab tirumotecan every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.	BIOLOGICAL: Sacituzumab tirumotecan Given by IV infusion. DRUG: Fluorouracil (5-FU) 5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks. DRUG: Leucovorin (LV) or levoleucovorin LV or levoleucovorin is administered by IV infusion every 2 weeks. DRUG: Rescue medication 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. Re DRUG: Supportive care measures 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 a DRUG: Cisplatin Given by IV infusion. BIOLOGICAL: Pembrolizumab Given by IV infusion.
EXPERIMENTAL: Sacituzumab tirumotecan + Cisplatin + Pembrolizumab Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (u	BIOLOGICAL: Sacituzumab tirumotecan Given by IV infusion. DRUG: Cisplatin Given by IV infusion. BIOLOGICAL: Pembrolizumab Given by IV infusion.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Sacituzumab tirumotecan + Chemotherapy

Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerat

BIOLOGICAL: Sacituzumab tirumotecan

Given by IV infusion.

DRUG: Fluorouracil (5-FU)

5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.

DRUG: Leucovorin (LV) or levoleucovorin

LV or levoleucovorin is administered by IV infusion every 2 weeks.

DRUG: Rescue medication

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. Re

DRUG: Supportive care measures

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 a

EXPERIMENTAL: Sacituzumab tirumotecan

Participants will receive sacituzumab tirumotecan every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.

BIOLOGICAL: Sacituzumab tirumotecan

Given by IV infusion.

DRUG: Fluorouracil (5-FU)

5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.

DRUG: Leucovorin (LV) or levoleucovorin

LV or levoleucovorin is administered by IV infusion every 2 weeks.

DRUG: Rescue medication

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. Re

DRUG: Supportive care measures

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 a

DRUG: Cisplatin

Given by IV infusion.

BIOLOGICAL: Pembrolizumab

Given by IV infusion.

EXPERIMENTAL: Sacituzumab tirumotecan + Cisplatin + Pembrolizumab

Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (u

BIOLOGICAL: Sacituzumab tirumotecan

Given by IV infusion.

DRUG: Cisplatin

Given by IV infusion.

BIOLOGICAL: Pembrolizumab

Given by IV infusion.

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)	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. The number of participants who experience a DLT will be reported.	Up to approximately 4 weeks
Number of Participants Who Experience One or More Adverse Events (AEs)	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.	Up to approximately 63 months
Number of Participants who Discontinue Study Treatment due to an AE	An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.	Up to approximately 63 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)	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.	Up to approximately 63 months

Secondary Outcome Measures	Measure Description	Time Frame
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR	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.	Up to approximately 63 months
Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR	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.	Up to approximately 63 months
Overall Survival (OS)	OS is the length of time from when the participant starts treatment until death from any cause	Up to approximately 63 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Toll Free Number

Phone Number: 1-888-577-8839

Email: Trialsites@msd.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Has one of the following cancers:

Unresectable or metastatic colorectal cancer and has received prior therapy for the cancer
Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer
Advanced and/or unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer
Advanced and/or unresectable BTC and has not received prior therapy for the cancer
For participants who have received prior therapy for cancer: Has recovered from any side effects due to previous cancer treatment

History of severe eye disease
For participants who have received prior therapy for cancer: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Medical Director, Merck Sharp & Dohme LLC

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record