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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Biliary Tract Cancer; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer

Treatments: Drug: Leucovorin (LV) or levoleucovorin; Drug: Fluorouracil (5-FU); Drug: Cisplatin; Drug: Supportive care measures; Drug: Rescue medication; Biological: Sacituzumab tirumotecan; Biological: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06428409

9999-02A

U1111-1298-8273 (Other Identifier)

MK-9999-02A (Other Identifier)

jRCT2031240178 (Registry Identifier)

2023-508703-21-00 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 3 patient groups

Sacituzumab tirumotecan + Chemotherapy

Experimental group

Description:

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 tolerate treatment.

Treatment:

Biological: Sacituzumab tirumotecan

Drug: Rescue medication

Drug: Supportive care measures

Drug: Fluorouracil (5-FU)

Drug: Leucovorin (LV) or levoleucovorin

Sacituzumab tirumotecan

Experimental group

Description:

Participants will receive sacituzumab tirumotecan in one of two dose levels 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.

Treatment:

Biological: Sacituzumab tirumotecan

Drug: Rescue medication

Drug: Supportive care measures

Sacituzumab tirumotecan + Cisplatin + Pembrolizumab

Experimental group

Description:

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 (up to approximately 6 months), and pembrolizumab on Day 1 of each 3-week cycle for up to approximately 2 years.

Treatment:

Biological: Pembrolizumab

Biological: Sacituzumab tirumotecan

Drug: Rescue medication

Drug: Supportive care measures

Drug: Cisplatin