C16 Malignant neoplasm of stomach Malignant neoplasm of stomach
Conditions
Interventions
MK-2870 Vial with lyophilized powder for intravenous infusion. Dose concentration: 200 mg vial. It will be administered at a dose of 4mg/kg by intravenous infusion on days 1, 15 and 29 of each 42-day
Sponsors
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Demographics: Is an individual of any sex/gender and is at least 18 years of age at the time of providing the informed consent. Type of Participant and Disease Characteristics: Participants are eligible regardless of HER2 status. If HER2 status is unknown, sites should follow local standards to determine if HER2 testing is required as SOC. Participants who are HER2+ must have previously received trastuzumab where available/appropriate. Note: Participants who received prior trastuzumab-deruxtecan/T-DXd (topoisomerase 1 inhibitor-based ADC) in any line are not eligible. Type of Participant and Disease Characteristics: Has a histologically- or cytologically-confirmed diagnosis of advanced, unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma. Type of Participant and Disease Characteristics: Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions. Type of Participant and Disease Characteristics: Has received, and progressed on, at least 2 prior chemotherapy and/or immunotherapy regimens. Note: For the purpose of this study, perioperative, neoadjuvant, and adjuvant chemotherapy regimens will not count as a prior regimen, unless the patient progressed while receiving adjuvant therapy or within 6 months of receiving adjuvant treatment. The date of progression and how progression was determined must be known with documentation available confirming progression on or after treatment. Note: Previous treatment regimens must have included a fluoropyrimidine and platinum doublet (as part of either a line of therapy or adjuvant treatment). Note: Prior immunotherapy may have been received alone or in combination with fluoropyrimidine and platinum-based chemotherapy. Male Participants: If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate the study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is: - MK-2870: 100 days - Irinotecan: 100 days - Paclitaxel: 100 days - Docetaxel: 100 days • Refrains from donating sperm PLUS either: • Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR • Uses contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview) as detailed below: - Uses a penile/external condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant PLUS partner use of an additional contraceptive method, as a condom may break or leak. Note: Participants capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use a penile/external condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate. - Contraceptive use by participants capable of producing sperm should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the lo
Exclusion criteria
Exclusion criteria: Medical Conditions: Has experienced weight loss >20% over 3 months before the first dose of study intervention. Medical Conditions: Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing. Medical Conditions: Has Grade =2 peripheral neuropathy. Medical Conditions: Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea). Medical Conditions: Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention. Medical Conditions: Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before the first dose of study intervention. Participants who are receiving diuretic drugs for other reasons are eligible. Consult with the Sponsor if the participant has more than trivial/trace fluid accumulation. Prior/Concomitant Therapy: Received prior treatment with a TROP2-targeted ADC, a topoisomerase 1 inhibitor-based ADC, and/or a topoisomerase 1 inhibitor-based chemotherapy. Prior/Concomitant Therapy: Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention. Prior/Concomitant Therapy: Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has had radiation pneumonitis. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention. Prior/Concomitant Therapy: Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. Refer to Section 6.5 for information on COVID-19 vaccines. Prior/Concomitant Therapy: Is currently receiving a strong and/or moderate inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study. The required washout period before starting MK-2870 is 2 weeks. Note: A list of strong inhibitors or induces of CYP3A4 can be found at the following website: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-anddrug-interactions-table-substrates-inhibitors-and-inducers. Prior/Concurrent Clinical Study Experience: Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention. Diagnostic Assessments: Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded. Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score =6, and PSA <10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not exclu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stratified Cox model with Efron's method for handling ties to evaluate the magnitude of the difference between treatments. NAME OF THE RESULT: Efficacy endpoints: Overall survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Time from randomization to death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Stratified Cox model with Efron's method for handling ties to evaluate the magnitude of the difference between treatments. NAME OF THE RESULT: Efficacy endpoints: Overall survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Time from randomization to death from any cause.;Cox model stratified with the Efron method for handling ties to assess the magnitude of the difference between treatments. NAME OF THE RESULT: Efficacy endpoints: Progression-free survival (PFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Time from randomization to first documented disease progression according to RECIST 1.1 as assessed by BICR or death from any cause, whichever occurs first.;Stratified Miettinen and Nurminen method. NAME OF THE RESULT: Efficacy assessment criteria: Objective response (OR) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: It is a confirmed CR or PR according to RECIST 1.1 as evaluated by the BICR.;For participants demonstrating confirmed CR or PR NAME OF THE RESULT: Efficacy Endpoints: Duration of Response (DOR) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Time from first documented evidence of confirmed CR or PR to first documented date of disease progression illness or death from any cause, whichever comes first.;By clinical review of all relevant parameters, including AEs, laboratory test results and vital signs. NAME OF THE RESULT: Safety endpoints: Safety and tolerability PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: To be performed during the course of the study: AEs will be reported up to 30 days after the last dose; SAEs will be reported up to 30 days after the last dose or any period if it is considered related to the investigational product. Laboratory tests a | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea South, Malasya, Mexico, Peru, Poland, Spain, Sweden, Taiwan, Thailand, Turkey, United Kindgdom, United States, Vietnam
Contacts
Public ContactNELVA GARCIA
MERCK SHARP & DOHME PERU S.R.L.
Outcome results
None listed