A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
Trial design
Design model
Parallel
Treatments tested in this trial
Sacituzumab tirumotecan
Biological/VaccineGiven by IV infusion.
Fluorouracil (5-FU)
Drug5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.
Leucovorin (LV) or levoleucovorin
DrugLV or levoleucovorin is administered by IV infusion every 2 weeks.
Rescue medication
DrugParticipants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 \[H1\] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.
Supportive care measures
DrugParticipants 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. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.
Cisplatin
DrugGiven by IV infusion.
Pembrolizumab
Biological/VaccineGiven by IV infusion.
Treatment groups
220 Participants
are divided into 3 treatment groupsGroup A: Sacituzumab tirumotecan + ChemotherapyExperimental treatment 5 interventions
Group B: Sacituzumab tirumotecanExperimental treatment 3 interventions
Group C: Sacituzumab tirumotecan + Cisplatin + PembrolizumabExperimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to approximately 4 weeks2
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.
Time frame
Up to approximately 63 months3
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.
Time frame
Up to approximately 63 months4
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 confirmed 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.
Time frame
Up to approximately 63 monthsSecondary outcomes
1
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.
Time frame
Up to approximately 63 months2
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.
Time frame
Up to approximately 63 months3
Overall Survival (OS)
OS is the length of time from when the participant starts treatment until death from any cause
Time frame
Up to approximately 63 monthsSponsors and contacts
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Source ClinicalTrials.gov