Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)

• ClinicalTrials.gov Identifier: NCT03635567
• Recruitment Status: Active, not recruiting
• First Posted: August 17, 2018
• Results First Posted: October 12, 2023
• Last Update Posted: January 17, 2024
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: August 15, 2018
• First Posted Date: August 17, 2018
• Results First Submitted Date: September 20, 2023
• Results First Posted Date: October 12, 2023
• Last Update Posted Date: January 17, 2024
• Actual Study Start Date: October 25, 2018
• Actual Primary Completion Date: October 3, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 20, 2023)

• Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 [ Time Frame: Up to approximately 46 months ]
  PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥1 is presented.
• PFS Per RECIST 1.1 as Assessed by Investigator in All Participants [ Time Frame: Up to approximately 46 months ]
  PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants is presented.
• PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10 [ Time Frame: Up to approximately 46 months ]
  PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥10 is presented.
• Overall Survival (OS) in Participants With PD-L1 CPS ≥1 [ Time Frame: Up to approximately 46 months ]
  OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥1 is presented.
• OS in All Participants [ Time Frame: Up to approximately 46 months ]
  OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants is presented.
• OS in Participants With PD-L1 CPS ≥10 [ Time Frame: Up to approximately 46 months ]
  OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥10 is presented.

Original Primary Outcome Measures (submitted: August 15, 2018)

• Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 2 years ]
  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by BICR will be presented.
• Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]
  OS is defined as the time from randomization to death due to any cause. The OS will be presented.

Current Secondary Outcome Measures (submitted: October 28, 2023)

• Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator [ Time Frame: Up to approximately 46 months ]
  ORR was defined as the percentage of the participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The ORR per RECIST 1.1 as assessed by Investigator is presented.
• Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator [ Time Frame: Up to approximately 46 months ]
  For participants who demonstrate CR or PR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR per RECIST 1.1 as assessed by Investigator is presented.
• Percentage of Participants That Were PFS Event-Free (PFS Rate) at Month 12 Per RECIST 1.1 as Assessed by Investigator [ Time Frame: 12 months ]
  PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS Rate was defined as the percentage of participants that were PFS event-free at Month 12. The PFS Rate per RECIST 1.1 as assessed by Investigator at Month 12 is presented.
• PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 46 months ]
  PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by BICR is presented.
• Number of Participants Who Experienced an Adverse Event (AE) [ Time Frame: Up to approximately 46 months ]
  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced an AE is presented.
• Number of Participants Who Experienced a Serious AE (SAE) [ Time Frame: Up to approximately 46 months ]
  An SAE was defined as any untoward medical occurrence that, at any dose: a.) Resulted in death; b.) Was life-threatening; c.) Required inpatient hospitalization or prolongation of existing hospitalization; d.) Resulted in persistent or significant disability/incapacity; e.) Was a congenital anomaly/birth defect; f.) Other important medical events; h.) Was a new cancer (that is not a condition of the study) or i.) Was associated with an overdose. The number of participants who experienced an SAE is presented.
• Number of Participants Who Experienced an Immune-related AE (irAE) [ Time Frame: Up to approximately 46 months ]
  AEs associated with pembrolizumab exposure may be a result of an immune response. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. For this study irAEs included, but were not limited to: -Pneumonitis;

  • Diarrhea/Colitis;
  • Aspartate transaminase (AST)/Alanine transaminase (ALT) elevation or Increased bilirubin;
  • Type 1 diabetes mellitus or Hyperglycemia;
  • Hypophysitis;
  • Hyperthyroidism;
  • Hypothyroidism;
  • Nephritis and Renal dysfunction; and
  • Myocarditis. The number of participants who experienced an irAE is presented.
• Number of Participants Who Discontinued Study Treatment Due to an AE [ Time Frame: Up to approximately 43 months ]
  The number of participants who discontinued study treatment due to an AE is presented.
• Number of Participants With a 10-point Change From Baseline in Quality of Life (QoL) Based on the European Organisation for the Research & Treatment of Cancer (EORTC) QoL Questionnaire-30 (QLQ-C30) Combined Global Score [ Time Frame: Baseline (Cycle 1 Day 1: Predose) and up to approximately 46 months ]
  The EORTC QLQ-C30 is a questionnaire to assess the quality of life of cancer patients. Participant responses to "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) are scored on a 7-point scale (1= Very poor to 7=Excellent). Raw scores are standardized with linear transformation so that scores range from 0-100. A higher combined score indicates a better overall health status. Participant post-baseline scores were classified based on change from baseline, "Improved": a ≥10-point improvement in score and confirmed by the next visit; "Stable": a ≥10-point increase or <10-point change in score OR a <10-point change in score and a ≥10-point increase in score at the next visit; or "Deteriorated": a ≥10-point deterioration in score when the criteria for improvement/stability weren't met. Participants who didn't meet "Improved", "Stable", or "Deteriorated" criteria reported as "Other".

Original Secondary Outcome Measures (submitted: August 15, 2018)

• Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR [ Time Frame: Up to approximately 2 years ]
  ORR is defined as the percentage of the participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The ORR per RECIST 1.1 as assessed by BICR will be presented.
• Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR [ Time Frame: Up to approximately 2 years ]
  For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR per RECIST 1.1 as assessed by BICR will be presented.
• Month 12 PFS Rate Per RECIST 1.1 as Assessed by BICR [ Time Frame: Month 12 ]
  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS Rate per RECIST 1.1 as assessed by BICR at Month 12 will be presented
• Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: From randomization through 30 days after last dose of study treatment (Up to approximately 25 months) ]
  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
• Number of Participants Who Experience a Serious AE (SAE) [ Time Frame: From randomization through 90 days after last dose of study treatment (Up to approximately 27 months) ]
  An SAE is defined as any untoward medical occurrence that, at any dose: a.) Results in death; b.) Is life-threatening; c.) Requires inpatient hospitalization or prolongation of existing hospitalization; d.) Results in persistent or significant disability/incapacity; e.) Is a congenital anomaly/birth defect; f.) Other important medical events; h.) Is a new cancer (that is not a condition of the study) or i.) Is associated with an overdose. The number of participants who experience an SAE will be presented.
• Number of Participants Who Experience an Immune-related AE (irAE) [ Time Frame: From randomization through 90 days after last dose of study treatment for serious irAEs (Up to approximately 27 months); From randomization through 30 days after last dose of study treatment for nonserious irAEs (Up to approximately 25 months) ]
  AEs associated with pembrolizumab exposure may be a result of an immune response. These irAEs may occur shortly after the first dose or several months after the last dose of pembrolizumab treatment and may affect more than one body system simultaneously. For this study irAEs include, but are not limited to: -Pneumonitis;

  • Diarrhea/Colitis;
  • Aspartate transaminase (AST)/Alanine transaminase (ALT) elevation or Increased bilirubin;
  • Type 1 diabetes mellitus or Hyperglycemia;
  • Hypophysitis;
  • Hyperthyroidism;
  • Hypothyroidism;
  • Nephritis and Renal dysfunction; and
  • Myocarditis. The number of participants who experience an irAE will be presented.
• Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 2 years ]
  The number of participants who discontinue study treatment due to an AE will be presented.
• Number of Participants with a 10-point Change from Baseline in Quality of Life (QoL) Based on the European Organisation for the Research & Treatment of Cancer (EORTC) QoL Questionnaire-30 (QLQ-C30) Global Score [ Time Frame: Baseline (Cycle 1 Day 1: Predose) and up to 30 days after last dose of study treatment (Up to approximately 25 months) ]
  The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. It incorporates 5 functional scales (physical, role, cognitive, emotional & social), 3 symptom scales (fatigue, pain, & nausea & vomiting), a global health status/QoL scale, & single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation & diarrhoea) & perceived financial impact of the disease. All of the scales & single-item measures range in score from 0 to 100. A 10-point change in the EORTC QLQ-C30 score is perceived to be clinically meaningful. Participant post-baseline EORTC QLQ-C30 scores will be classified as "improvement", "stable", or "deterioration" according to a 10-point or greater change for EORTC QLQ-C30 global score. The number of participants with "improved", "stable", or "deteriorated" symptoms/scales will be presented.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)
• Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)

Brief Summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.

The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Cervical Cancer

Intervention

• Biological: Pembrolizumab
  IV infusion
  Other Names:

  • MK-3475
  • KEYTRUDA®
• Drug: Paclitaxel
  IV infusion
  Other Name: TAXOL®
• Drug: Cisplatin
  IV infusion
  Other Name: PLATINOL®
• Drug: Carboplatin
  IV infusion
  Other Name: PARAPLATIN®
• Biological: Bevacizumab
  IV infusion
  Other Name: AVASTIN®
• Drug: Placebo to pembrolizumab
  IV infusion
  Other Name: Normal Saline or Dextrose solution

Study Arms

• Experimental: Pembrolizumab+Chemotherapy
  On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
  Interventions:

  • Biological: Pembrolizumab
  • Drug: Paclitaxel
  • Drug: Cisplatin
  • Drug: Carboplatin
  • Biological: Bevacizumab
• Placebo Comparator: Placebo+Chemotherapy
  On Day 1 of each 21-day cycle, participants receive an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments are administered until disease progression or toxicity.
  Interventions:

  • Drug: Paclitaxel
  • Drug: Cisplatin
  • Drug: Carboplatin
  • Biological: Bevacizumab
  • Drug: Placebo to pembrolizumab

Publications *

• Monk BJ, Colombo N, Tewari KS, Dubot C, Caceres MV, Hasegawa K, Shapira-Frommer R, Salman P, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Tekin C, Li K, Keefe SM, Lorusso D; KEYNOTE-826 Investigators. First-Line Pembrolizumab + Chemotherapy Versus Placebo + Chemotherapy for Persistent, Recurrent, or Metastatic Cervical Cancer: Final Overall Survival Results of KEYNOTE-826. J Clin Oncol. 2023 Dec 20;41(36):5505-5511. doi: 10.1200/JCO.23.00914. Epub 2023 Nov 1.
• Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yanez E, Gumus M, Olivera Hurtado de Mendoza M, Samouelian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435. Epub 2021 Sep 18.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 19, 2022): 617
• Original Estimated Enrollment (submitted: August 15, 2018): 600
• Estimated Study Completion Date: June 4, 2024
• Actual Primary Completion Date: October 3, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation). Prior chemotherapy utilized as a radiosensitizing agent and completed at least 2 weeks prior to randomization with resolution of all treatment-related toxicities is allowed. AEs due to previous treatments should be resolved to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are eligible.
• Not pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab
• Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
• Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization
• Has adequate organ function

Exclusion Criteria:

• A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with known brain metastases may participate provided that the brain metastases have been previously treated (except with chemotherapy) and are radiographically stable.
• 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, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast cancer) that have undergone potentially curative therapy are not excluded.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
• Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a known history of Hepatitis B or known active Hepatitis C virus infection
• Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
• Has 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 co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137)
• Has received prior systemic chemotherapy for treatment of cervical cancer.
• Has not recovered adequately from toxicity and/or complications from major surgery prior to randomization
• Has received prior radiotherapy within 2 weeks prior to randomization. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
• Has received a live vaccine within 30 days prior to randomization
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
• Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
• Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days following last dose of pembrolizumab/placebo and 210 days following last dose of chemotherapy/bevacizumab
• Has had an allogeneic tissue/solid organ transplant

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Canada, Chile, Colombia, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United States

Administrative Information

• NCT Number: NCT03635567
• Other Study ID Numbers: 3475-826; MK-3475-826 ( Other Identifier: Merck ); KEYNOTE-826 ( Other Identifier: Merck ); 184183 ( Registry Identifier: JAPAC-CTI ); 2018-001440-53 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Current Responsible Party: Merck Sharp & Dohme LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Merck Sharp & Dohme LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

• PRS Account: Merck Sharp & Dohme LLC
• Verification Date: January 2024