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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06036836
Registration number
NCT06036836
Ethics application status
Date submitted
21/08/2023
Date registered
14/09/2023
Titles & IDs
Public title
Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)
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Scientific title
A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) With Pembrolizumab (MK-3475) in Selected Solid Tumors (KeyForm-010)
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Secondary ID [1]
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MK-4280A-010
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Secondary ID [2]
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4280A-010
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Tumor
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Cutaneous Squamous Cell Carcinoma
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Endometrial Cancer
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - favezelimab/pembrolizumab
Treatment: Other - pembrolizumab
Treatment: Drugs - lenvatinib
Experimental: Favezelimab/Pembrolizumab - Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via an intravenous (IV) infusion every 3 weeks (Q3W) for 3 cycles in the neoadjuvant period and 14 cycles of adjuvant therapy. Each cycle is 21 days. Participants who do not complete all 3 neoadjuvant cycles should have additional cycles in the adjuvant period so that the total number of study intervention administrations is 17 treatment cycles.
Experimental: Pembrolizumab - Participants will receive 200 mg pembrolizumab via an IV infusion Q3W for 3 cycles in the neoadjuvant period and 14 cycles of adjuvant therapy. Each cycle is 21 days. Participants who do not complete all 3 neoadjuvant cycles should have additional cycles in the adjuvant period so that the total number of study intervention administrations is 17 treatment cycles.
Experimental: Favezelimab/Pembrolizumab + Lenvatinib (Cohort B) - Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib every day (QD) 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met.
Experimental: Pembrolizumab + Lenvatinib (Cohort B) - Participants will receive 200 mg pembrolizumab via IV infusion Q3W for up to 35 cycles (each cycle is 21 days) PLUS lenvatinib QD 20 mg orally until disease progression, unacceptable toxicity, or discontinuation criteria are met.
Treatment: Other: favezelimab/pembrolizumab
IV infusion
Treatment: Other: pembrolizumab
IV infusion
Treatment: Drugs: lenvatinib
Oral administration of capsule
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pathological Complete Response (pCR) - Cohort A
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Assessment method [1]
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pCR is defined as complete absence of viable tumor in the surgical resection sample as assessed by central review of the pathology results. Number of Cohort A participants with pCR will be reported.
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Timepoint [1]
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Up to approximately 22 months
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Primary outcome [2]
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Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Investigator - Cohort B
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Assessment method [2]
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The ORR is defined as the percentage of participants who have an OR per investigator assessment. The OR is defined as a 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 Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
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Timepoint [2]
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Up to approximately 21 months
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Secondary outcome [1]
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Overall Survival (OS) - All Cohorts
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Assessment method [1]
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OS is defined as the time from randomization to death from any cause.
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Timepoint [1]
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Up to approximately 41 months
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Secondary outcome [2]
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Clinical Benefit Rate - Cohort A
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Assessment method [2]
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Clinical benefit rate is defined as the percentage of participants who have clinical benefit. Clinical benefit is defined as pCR in participants who undergo surgery or clinical complete response (cCR) \[defined as residual tumor not visible on clinical exam or on imaging and a negative biopsy, if biopsy is available, in participants who decline surgery.
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Timepoint [2]
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Up to approximately 22 months
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Secondary outcome [3]
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Event-Free Survival (EFS) - Cohort A
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Assessment method [3]
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EFS is defined as the time from randomization to first progression prior to surgical resection as assessed by investigator, inability to resect tumor, recurrence (postsurgical resection), or death from any cause, whichever occurs first.
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Timepoint [3]
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Up to approximately 41 months
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Secondary outcome [4]
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Major Pathological Response (mPR) - Cohort A
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Assessment method [4]
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mPR is defined as =10% of viable tumor cells in the surgical resection sample as assessed by central review of the pathology results. The number of Cohort A participants with mPR will be reported.
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Timepoint [4]
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Up to approximately 22 months
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Secondary outcome [5]
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ORR per RECIST 1.1 as assessed by Investigator - Cohort A
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Assessment method [5]
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The ORR is defined as the percentage of participants who have an OR per investigator assessment. The OR is defined as a 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 Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
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Timepoint [5]
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Up to approximately 22 months
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Secondary outcome [6]
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Number of participants with an adverse event (AE) - Cohorts A and B
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Assessment method [6]
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An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who experience an AE will be reported.
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Timepoint [6]
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Up to approximately 41 months
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Secondary outcome [7]
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Number of participants discontinuing from study therapy due to AE - Cohorts A and B
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Assessment method [7]
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An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who discontinue study treatment due to an AE will be reported.
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Timepoint [7]
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Up to approximately 41 months
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Secondary outcome [8]
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Number of participants experiencing perioperative complications - Cohort A
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Assessment method [8]
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The number of participants who experience perioperative complications will be assessed.
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Timepoint [8]
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Up to approximately 18 weeks
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Secondary outcome [9]
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Number of participants with an AE that precludes surgery/initiation of adjuvant therapy - Cohort A
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Assessment method [9]
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An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of Cohort A participants with an AE that precludes surgery or initiation of adjuvant therapy will be reported.
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Timepoint [9]
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Up to approximately 2 months
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Secondary outcome [10]
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Progression Free Survival (PFS) - Cohort B
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Assessment method [10]
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PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by the investigator. Per RECIST 1.1, or by histopathologic confirmation of disease progression (PD), 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. Unequivocal progression of non-target lesions is also considered PD.
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Timepoint [10]
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Up to approximately 41 months
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Secondary outcome [11]
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Duration of Response (DOR) - Cohort B
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Assessment method [11]
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DOR is defined as the time from first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) 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 Blinded Independent Central Review (BICR) will be presented.
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Timepoint [11]
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Up to approximately 41 months
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Eligibility
Key inclusion criteria
Inclusion Criteria
Cohort A only
* Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
* Stage II to Stage IV disease without distant metastasis (M1). cSCC tumors arising in the head and neck will be staged according to American Joint Committee on Cancer (AJCC) Edition (Ed.) 8 and cSCC tumors arising in non-head and neck locations will be staged according to Union for International Cancer Control (UICC) Ed. 8
* Is systemic treatment naïve
* Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample of a tumor lesion not previously irradiated has been provided
* Is an individual of any sex/gender, at least 18 years of age at the time of providing the informed consent
Cohort B only
* Histologically confirmed diagnosis of endometrial cancer (EC) that is not deficient in mismatch repair (dMMR) proficient in mismatch repair (pMMR) as documented by a local test report
* Documented evidence of stage IVB (per 2009 International Federation of Gynecology and Obstetrics (FIGO) staging), recurrent, or metastatic EC, and are not candidates for curative surgery or radiation
* Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC in any setting
* Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) by investigator (before first dose of study intervention)
* Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
* Has adequately controlled blood pressure without antihypertensive medication
All Cohorts
* Agrees to follow contraception guidelines if a participant of childbearing potential
* Has a life expectancy >3 years per investigator assessment
* Has adequate organ function
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* If positive for hepatitis B, has received antiviral therapy for =4 weeks and undetectable viral load prior to randomization
* If positive for hepatitis C, has undetectable viral load at screening
* If positive for human immunodeficiency virus (HIV), has well-controlled HIV on a stable highly active antiretroviral therapy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
All Cohorts
* Has known hypersensitivity to active substances or their excipients including previous clinically significant hypersensitivity reaction to treatment with other monoclonal antibody (mAb)
* History of allogeneic tissue/solid organ transplant
Cohort A only
* Received prior radiotherapy to the index lesion (in-field lesion)
* Participants for whom the primary site of cSCC was anogenital area (penis, scrotum, vulva, perianal region) are not eligible
Cohort B
* Has had major surgery within 3 weeks prior to first dose of study interventions
* Has preexisting =Grade 3 gastrointestinal or non-gastrointestinal fistula
* Has urine protein =1 g/24 hours
* Has a left ventricle ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multi-gated acquisition (MUGA) or echocardiogram (ECHO)
* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
9/03/2027
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Actual
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Sample size
Target
160
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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St Vincent's Hospital-The Kinghorn Cancer Centre ( Site 0005) - Darlinghurst
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Recruitment hospital [2]
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Royal North Shore Hospital ( Site 0008) - St Leonards
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Recruitment hospital [3]
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Blacktown Hospital ( Site 0003) - Sydney
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Recruitment hospital [4]
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Royal Brisbane and Women's Hospital ( Site 0002) - Brisbane
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Recruitment hospital [5]
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The Alfred Hospital ( Site 0004) - Melbourne
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Recruitment hospital [6]
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Fiona Stanley Hospital ( Site 0006) - Murdock
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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2148 - Sydney
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Recruitment postcode(s) [4]
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4029 - Brisbane
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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6150 - Murdock
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Connecticut
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United States of America
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Massachusetts
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United States of America
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New Jersey
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Texas
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Canada
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Ontario
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Canada
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State/province [9]
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Quebec
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France
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State/province [10]
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Alsace
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Country [11]
0
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France
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State/province [11]
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Finistere
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Country [12]
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France
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State/province [12]
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Rhone-Alpes
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Country [13]
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France
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State/province [13]
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Paris
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Germany
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Nordrhein-Westfalen
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Italy
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Lombardia
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Italy
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State/province [16]
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Napoli
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Malaysia
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State/province [17]
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Johor
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Malaysia
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State/province [18]
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Kuala Lumpur
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Malaysia
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State/province [19]
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Sarawak
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Country [20]
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Netherlands
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State/province [20]
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Gelderland
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Country [21]
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Netherlands
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State/province [21]
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Zuid-Holland
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Netherlands
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State/province [22]
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Groningen
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Taiwan
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State/province [23]
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Taichung
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0
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Taiwan
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State/province [24]
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Tainan
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Taiwan
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State/province [25]
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Taipei
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Country [26]
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Turkey
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State/province [26]
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Istanbul
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Country [27]
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Turkey
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State/province [27]
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Ankara
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate pathological complete response (pCR) rate of coformulated favezelimab/pembrolizumab (MK-4280A) or pembrolizumab as assessed by blinded central pathology review (BICR) in participants with cutaneous squamous cell carcinoma (cSCC) \[Cohort A\] and to evaluate lenvatinib in combination with coformulated favezelimab/pembrolizumab or pembrolizumab with respect to objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator in participants proficient in mismatch repair (pMMR) endometrial cancer (EC) \[Cohort B\].
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Trial website
https://clinicaltrials.gov/study/NCT06036836
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Toll Free Number
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Address
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Country
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06036836