D022 Bronchus and lung Bronchus and lung
Conditions
Interventions
MK-2870 in solution. Dose strength: 200 mg/20 mL vial. 4mg/kg will be administered by intravenous infusion, every two weeks on day 1, day 15 and day 29 of each 6-week cycle until a treatment discontin
Participants may be eligible for the second wave (9 additional cycles). The following drugs will also be administered: Antihistamines, H2 receptor antagonist, Acetaminophen (or equivalent) and Dexamet
Sponsors
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Additional Categories: A life expectancy of at least 3 months. Type of Participant and Disease Characteristics: Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC (Stage IV: M1a, M1b, M1c, AJCC Staging Manual, version 8). Note: Mixed tumors will be characterized by the predominant cell type (squamous or nonsquamous); however, small cell elements are not permitted. Type of Participant and Disease Characteristics: Confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R] AND absence of ALK and ROS1 gene rearrangements). Note: If participant’s tumor has a predominantly squamous histology, molecular testing for EGFR mutation and ALK and ROS1 translocations is not required. Note: The presence of a KRAS mutation in a participant’s tumor is permitted. Note: Due to insufficient sensitivity, negative ctDNA results for EGFR, ALK, and ROS1 cannot be used to satisfy this inclusion criterion. Type of Participant and Disease Characteristics: Has provided tumor tissue that demonstrates PD-L1 expression in =50% of tumor cells (TPS =50%) as assessed by IHC at a central laboratory. Note: Assessment of PD-L1 expression must be made before randomization, from provided archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated. Tumor tissue from after diagnosis of metastatic disease is preferred. Details pertaining to tumor tissue submission can be found in the Laboratory Manual. Demographics: Is an individual of any sex/gender, who is at least 18 years of age at the time of providing the informed consent. Participants Assigned Male Sex at Birth: If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of 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. - Pembrolizumab: No contraception required for participants capable of producing sperm. • 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 local label for any of the study interventions are more stringent than the requirement
Exclusion criteria
Exclusion criteria: Medical Conditions: Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements. Medical Conditions: Has Grade =2 peripheral neuropathy. Medical Conditions: 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 active inflammatory bowel disease requiring immunosuppressive medication or previous clear 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 the 6 months preceding study intervention. Prior/Concomitant Therapy: Received prior systemic anticancer therapy for their metastatic NSCLC. Note: Prior treatment with neoadjuvant or adjuvant therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC. Prior/Concomitant Therapy: Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). Note: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC. Prior/Concomitant Therapy: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. Prior/Concomitant Therapy: Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention. Prior/Concomitant Therapy: Requires treatment with a strong inhibitor or inducer of CYP3A4 at least 14 days before the first dose of study intervention and throughout the study. Note: a list of strong inhibitors or inducers of CYP3A4 can be found at the following website: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-druginteractions- table-substrates-inhibitors-and-inducers Prior/Concomitant Therapy: Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids. 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: Received prior treatment with a TROP2-targeted ADC. Prior/Concomitant Therapy: Received prior treatment with a topoisomerase I-containing ADC. Prior/Concurrent Clinical Study Experience: Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. Diagnostic Assessments: Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of elapsed time NAME OF THE RESULT: Efficacy endpoint: Overall Survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to the occurrence of death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of elapsed time NAME OF THE RESULT: Efficacy endpoint: Overall Survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to the occurrence of death from any cause.;Imaging scans. Evaluation of the BICR according to RECIST 1.1. Occurrence of death. NAME OF THE RESULT: Efficacy endpoint: Progression free survival .(PFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to first documented disease progression according to RECIST 1.1 by blinded independent central review (BICR) or death from any cause, whichever occurs first.;Imaging scans. Evaluation of the BICR according to RECIST 1.1. NAME OF THE RESULT: Efficacy endpoint: Objective response (OR) defined as a confirmed complete response (CR) or partial response (PR) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: It will be carried out during the development of the study: The first imaging during treatment will be performed 6 weeks (+7 days) after randomization. Subsequent imaging will occur every 6 weeks (±7 days) from randomization to week 48 and every 12 weeks (±7 days) thereafter, as indicated in the schedule.;Imaging scans. Evaluation of the BICR according to RECIST 1.1. Disease progression or death. NAME OF THE RESULT: Efficacy endpoint: Duration of response (DOR) For participants who demonstrate confirmed CR or PR. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Time from first documented evidence of CR or PR to disease progression or death from any cause, whichever comes first.;Clinical review of all relevant parameters, including AEs/SAEs, 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 PRI | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, France, Germany, Italy, Japan, Korea South, Mexico, Nederland, Peru, Poland, Portugal, Spain, Taiwan, Thailand, Turkey, United Kindgdom, United States, Vietnam
Contacts
Public ContactNELVA GARCIA
MERCK SHARP & DOHME PERU S.R.L.
Outcome results
None listed