Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001)

NCT03179436 | Completed Phase 1 Results FDA Drug

• 4 other identifiers: 1308-001MK-1308-0011738202019-003703-35
• Study Type: interventional
• Target: 415
• Locations: 16 countries
• Sites: 53

Brief Summary

This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of quavonlimab when used in combination with pembrolizumab in participants with advanced solid tumors.

Conditions

Advanced Solid Tumors

Keywords

Programmed Cell Death Protein 1 (PD-1, PD1),; Programmed Cell Death Ligand 1 (PD-L1, PDL1); Programmed Cell Death Ligand 2 (PD-L2, PDL2)

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With ≥1 Dose Limiting Toxicity (DLT)

  DLT was defined as toxicity that is possibly, probably, or definitely related to study therapy and may result in a change in the given dose. DLTs include Grade (Gr)4 non-hematologic toxicity (not laboratory); Gr 4 hematologic toxicity lasting ≥7 days (except thrombocytopenia); most non-hematologic AEs ≥ Gr 3 in severity; any Gr 3 or Gr 4 non-hematologic laboratory value that requires clinically significant medical intervention, leads to hospitalization, persists for \>1 week, or results in a drug-induced liver injury; Gr 3 or Gr 4 febrile neutropenia; a prolonged delay in initiating Cycle 2 or 3 of Dose Escalation or Cycle 2 of Dose Confirmation due to treatment-related toxicity; any treatment-related toxicity that causes the participant to discontinue treatment during the DLT observation period, and Gr 5 toxicity.

  Up to 6 weeks

• Number of Participants With ≥1 Adverse Event (AE)

  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, no analysis was planned for the cross over phase. The number of participants who experienced an AE are presented.

  Up to approximately 77 months

• Number of Participants Discontinuing Study Treatment Due to an AE

  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, no analysis was planned for the cross over phase. The number of participants who discontinued study treatment due to an AE are presented.

  Up to approximately 26 months

• Efficacy Expansion: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Based on Adjusted Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

  ORR is defined as the percentage of participants with 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 adjusted Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR in the concurrent randomized subset as assessed by Blinded Independent Central Review (BICR) will be presented. Per protocol, only data for arms F and G were presented for this endpoint.

  Up to approximately 72 months

Secondary Outcomes (10)

• Area Under the Plasma Concentration Time Curve (AUC) of Pembrolizumab

  At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F: Day 21 Cycle 3, Arm I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.

• Maximum Concentration (Cmax) of Pembrolizumab

  At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F: Day 21 Cycle 3, Arm I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.

• Minimum Concentration (Cmin) of Pembrolizumab

  At designated time points up to - Cohorts 1-3: Day 1 Cycle 4, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F: Day 21 Cycle 3, Arm I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.

• Area Under the Plasma Concentration Time Curve (AUC) of Quavonlimab (MK-1308)

  At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F, G, I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.

• Maximum Concentration (Cmax) of Quavonlimab

  At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F, G, I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.

Study Arms (12)

Escalation: Dose Level (DL) 1 Quavonlimab + Pembro: Cohort 1

EXPERIMENTAL

On Cycle 1, Day 1 of the Dose Escalation Phase, advanced solid tumor participants receive a single monotherapy dose lead-in with quavonlimab at dose level 1 (DL1). On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive quavonlimab at DL1 in combination with pembrolizumab (pembro) at pembrolizumab dose level 1 (PDL1) according to Schedule 1. For all subsequent cycles (starting with Cycle 6), all participants receive pembrolizumab monotherapy according to Schedule 1. Participants will be treated for up to 35 cycles total on study.

Biological: Quavonlimab; Biological: Pembrolizumab

Escalation: DL 2 Quavonlimab + Pembro: Cohort 2

EXPERIMENTAL

On Cycle 1, Day 1 of the Dose Escalation Phase, participants with advanced solid tumors except NSCLC receive a single monotherapy dose lead-in with quavonlimab at DL2. On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive quavonlimab at DL2 in combination with pembrolizumab at PDL1 according to Schedule 1. For all subsequent cycles (starting with Cycle 6), all participants receive pembrolizumab monotherapy according to Schedule 1. Participants will be treated for up to 35 cycles total on study.

Biological: Quavonlimab; Biological: Pembrolizumab

Escalation: DL 3 Quavonlimab + Pembro: Cohort 3

EXPERIMENTAL

On Cycle 1, Day 1 of the Dose Escalation Phase, participants with advanced solid tumors except NSCLC receive a single monotherapy dose lead-in with quavonlimab at DL3. On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive quavonlimab at DL3 in combination with pembrolizumab at PDL1 according to Schedule 1. For all subsequent cycles (starting with Cycle 6), all participants receive pembrolizumab monotherapy according to Schedule 1. Participants will be treated for up to 35 cycles total on study.

Biological: Quavonlimab; Biological: Pembrolizumab

Confirmation: DL 1 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm A

EXPERIMENTAL

On Cycle 1, Day 1 of the Dose Confirmation Phase and during all subsequent cycles, participants with NSCLC receive quavonlimab at DL1 in combination with pembrolizumab at PDL1, both according to Schedule 1. Participants will be treated for up to 35 cycles total on study.

Biological: Quavonlimab; Biological: Pembrolizumab

Confirmation: DL 1 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm B

EXPERIMENTAL

On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with NSCLC receive quavonlimab at DL1 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and quavonlimab at DL1 according to Schedule 2. Participants will be treated for up to 35 cycles total on study.

Biological: Quavonlimab; Biological: Pembrolizumab

Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm C

EXPERIMENTAL

On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with NSCLC receive quavonlimab at DL2 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and at DL2 quavonlimab according to Schedule 2. Participants will be treated for up to 35 cycles total on study.

Biological: Quavonlimab; Biological: Pembrolizumab

Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (SCLC): Arm D

EXPERIMENTAL

On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with SCLC receive quavonlimab at DL2 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and quavonlimab at DL2 according to Schedule 2. Participants will be treated for up to 35 cycles total on study.

Biological: Quavonlimab; Biological: Pembrolizumab

Confirmation: DL 2 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm E

EXPERIMENTAL

On Cycle 1, Day 1 of the Dose Confirmation Phase and during all subsequent cycles, participants with NSCLC receive quavonlimab at DL2 in combination with pembrolizumab at PDL1 according to Schedule 1. Participants will be treated for up to 35 cycles total on study.

Biological: Quavonlimab; Biological: Pembrolizumab

Expansion: DL1 Quavonlimab Schedule 2+PDL2 Pembro Schedule 2: Arm F

EXPERIMENTAL

On Cycle 1, Day 1 of the Efficacy Expansion Phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma receive quavonlimab at DL1 in combination with pembrolizumab at pembrolizumab dose level 2 (PDL2). Both quavonlimab and pembrolizumab will be administered according to Schedule 2 for up to 24 months on study.

Biological: Quavonlimab; Biological: Pembrolizumab

Expansion: DL1 Quavonlimab Schedule 2 Monotherapy: Arm G

EXPERIMENTAL

On Cycle 1, Day 1 of the Efficacy Expansion Phase and during all subsequent cycles, participants with PD-1/PD-L1 refractory melanoma receive quavonlimab at DL1 according to Schedule 2 for up to 24 months on study. Participants who demonstrate radiographically confirmed progressive disease in Arm G will be eligible to receive combination therapy with pembrolizumab (crossover).

Biological: Quavonlimab

Coformulation: Pembrolizumab/Quavonlimab Schedule 2: Arm I

EXPERIMENTAL

On Cycle 1, Day 1 of the Coformulation Phase and during all subsequent cycles, participants with advanced/metastatic solid tumors receive pembrolizumab/quavonlimab according to Schedule 2 for up to 24 months on study.

Drug: Pembrolizumab/Quavonlimab

Coformulation Phase in China: Pembrolizumab/Quavonlimab Schedule 2: Arm K

EXPERIMENTAL

On Cycle 1, Day 1 of the Coformulation Phase and during all subsequent cycles, participants in mainland China with advanced solid tumors receive pembrolizumab/quavonlimab according to Schedule 2 for up to 24 months on study.

Drug: Pembrolizumab/Quavonlimab

Interventions

Quavonlimab BIOLOGICAL

Quavonlimab is administered intravenously (IV) during the Dose Escalation Phase and Dose Confirmation Phase at either DL1 or DL2, and is administered IV during the Efficacy Expansion Phase at DL2.

Also known as: MK-1308

Confirmation: DL 1 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm A; Confirmation: DL 1 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm B; Confirmation: DL 2 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm E; Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm C; Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (SCLC): Arm D; Escalation: DL 2 Quavonlimab + Pembro: Cohort 2; Escalation: DL 3 Quavonlimab + Pembro: Cohort 3; Escalation: Dose Level (DL) 1 Quavonlimab + Pembro: Cohort 1; Expansion: DL1 Quavonlimab Schedule 2 Monotherapy: Arm G; Expansion: DL1 Quavonlimab Schedule 2+PDL2 Pembro Schedule 2: Arm F

Pembrolizumab BIOLOGICAL

Pembrolizumab is administered IV at PDL1 on Day 1 of each cycle starting Cycle 2 for the Dose Escalation Phase or starting Cycle 1 of the Dose Confirmation Phase. Pembrolizumab is administered IV at PDL2 on Day 1 of each cycle for the Efficacy Expansion Phase (Arm G).

Also known as: Keytruda®

Confirmation: DL 1 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm A; Confirmation: DL 1 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm B; Confirmation: DL 2 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm E; Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm C; Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (SCLC): Arm D; Escalation: DL 2 Quavonlimab + Pembro: Cohort 2; Escalation: DL 3 Quavonlimab + Pembro: Cohort 3; Escalation: Dose Level (DL) 1 Quavonlimab + Pembro: Cohort 1; Expansion: DL1 Quavonlimab Schedule 2+PDL2 Pembro Schedule 2: Arm F

Pembrolizumab/Quavonlimab DRUG

Pembrolizumab/Quavonlimab is a coformulated product composed of quavonlimab at DL1 in combination with pembrolizumab at dose level 2 (PDL2).

Also known as: MK-1308A

Coformulation Phase in China: Pembrolizumab/Quavonlimab Schedule 2: Arm K; Coformulation: Pembrolizumab/Quavonlimab Schedule 2: Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Dose Escalation Phase:
• Have any histologically- or cytologically-confirmed advanced/metastatic solid tumor (except NSCLC for Cohorts 2 and 3) by pathology report and have received, been intolerant to, been ineligible for, or refused all treatment known to confer clinical benefit
• For Dose Confirmation Phase NSCLC Arms (A, B, C, and E):
• Have newly diagnosed histologically or cytologically-confirmed stage IIIB/stage IV NSCLC. Epidermal growth factor receptor (EGFR)-and anaplastic lymphoma kinase (ALK) translocation-directed therapy is not indicated as primary therapy. Participant must not have received prior systemic treatment for advanced NSCLC or must have received previous neoadjuvant and adjuvant chemotherapies ≥6 months before dosing of study drug if prior systemic treatment was given for early stage disease
• For Dose Confirmation Phase SCLC Arm (Arm D):
• Have histologically- or cytologically-confirmed metastatic (Stage III/IV) SCLC with progressive disease after ≥1 platinum-based chemotherapy regimen. Participants with platinum-sensitive disease are eligible
• Have measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology
• Have Eastern Cooperative Oncology Group (ECOG) Performance Scale status of 0 or 1
• A female participant is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies:
• Is not a woman of child bearing potential (WOCBP) OR
• Is a WOCBP and using a contraceptive method that is highly effective during the intervention period and for at least 120 days after the last dose of pembrolizumab or pembrolizumab/quavonlimab, whichever comes last
• Female participants of childbearing potential must have negative urine or serum pregnancy test within 24 hours for urine and within 72 hours for serum prior to receiving the first dose of study treatment
• Male participants with a female partner(s) of child-bearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication and refrain from donating sperm during this period
• Must submit an evaluable baseline tumor sample for analysis (either a recent or archival tumor sample)
• For Efficacy Expansion Phase Arms F and G:

You may not qualify if:

• For all phases of the study: Has received previous treatment with another agent targeting cytotoxic T lymphocyte leukocyte antigen (CTLA)-4
• For Dose Confirmation Phase:
• Has received previous treatment with another agent targeting programmed cell death protein 1 (PD-1), programmed cell death ligand 1 (PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
• Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to the first dose of study therapy, or has not recovered to Common Toxicity Criteria for Adverse Events (CTCAE) Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
• Has received lung radiation therapy of \>30 Gray (Gy) within 6 months before the first dose of study treatment
• Is currently participating and receiving study therapy in a study of an investigational agent or has participated and received study therapy in a study of an investigational agent or has used an investigational device within 28 days of administration of quavonlimab.
• Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
• For Dose Escalation Cohorts (1-3) and Dose Confirmation Arms (A-E):
• Has known untreated central nervous system (CNS) metastases. Has known carcinomatous meningitis
• Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse events (irAE)
• Has had a severe hypersensitivity reaction to treatment with any monoclonal antibody or components of the study drug
• Has any active infection requiring therapy
• Has a history of interstitial lung disease, history of noninfectious pneumonitis that required steroids (or has current pneumonitis), or history of inflammatory bowel disease
• Has an active autoimmune disease that has required systemic treatment in the past 2 years
• Has clinically significant cardiac disease

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (53)

Banner MD Anderson Cancer Center ( Site 0013)

Gilbert, Arizona, 85234, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)

Hackensack, New Jersey, 07601, United States

Location

Tennessee Oncology Nashville ( Site 0004)

Nashville, Tennessee, 37203, United States

Location

South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001)

San Antonio, Texas, 78229, United States

Location

Inova Schar Cancer Institute ( Site 1001)

Fairfax, Virginia, 22031-4867, United States

Location

Blacktown Hospital. Western Sydney local health district ( Site 0009)

Blacktown, New South Wales, 2148, Australia

Location

Calvary Mater Newcastle ( Site 0025)

Waratah, New South Wales, 2298, Australia

Location

Melanoma Institute Australia ( Site 0017)

Wollstonecraft, New South Wales, 2065, Australia

Location

Gallipoli Medical Research Foundation-GMRF CTU ( Site 0019)

Brisbane, Queensland, 4120, Australia

Location

Cairns and Hinterland Hospital and Health Service ( Site 0020)

Cairns, Queensland, 4870, Australia

Location

Ashford Cancer Centre Research ( Site 0012)

Kurralta Park, South Australia, 5037, Australia

Location

Ballarat Health Services ( Site 0022)

Ballarat, Victoria, 3350, Australia

Location

Alfred Health ( Site 0018)

Melbourne, Victoria, 3004, Australia

Location

Sunnybrook Research Institute ( Site 1103)

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre ( Site 1104)

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1102)

Montreal, Quebec, H2X 0A9, Canada

Location

Jewish General Hospital ( Site 1105)

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre ( Site 1101)

Montreal, Quebec, H4A 3J1, Canada

Location

Fundacion Arturo Lopez Perez ( Site 5601)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Beijing Cancer hospital-Digestive Oncology ( Site 5001)

Beijing, Beijing Municipality, 100142, China

Location

Chongqing Cancer Hospital-Phase 1 Unite ( Site 5004)

Chongqing, Chongqing Municipality, 400030, China

Location

Sir Run Run Shaw Hospital-Medical Oncology ( Site 5003)

Hangzhou, Zhejiang, 310016, China

Location

Hopital La Timone ( Site 3303)

Marseille, Bouches-du-Rhone, 13005, France

Location

Institut Bergonie ( Site 3306)

Bordeaux, Gironde, 33076, France

Location

CHRU Lille - Hopital Claude Huriez ( Site 3302)

Lille, Nord, 59037, France

Location

CH Lyon Sud Hospices Civils de Lyon ( Site 3307)

Pierre-Bénite, Rhone, 69495, France

Location

Gustave Roussy ( Site 3305)

Villejuif, Val-de-Marne, 94800, France

Location

Regional General Hospital of Athens "Laiko" ( Site 3001)

Athens, Attica, 115 27, Greece

Location

Rambam Medical Center ( Site 0003)

Haifa, 3109601, Israel

Location

Hadassah Ein Karem Hebrew University Medical Center ( Site 0021)

Jerusalem, 9112001, Israel

Location

Sheba Medical Center - Cancer Center ( Site 0002)

Ramat Gan, 52621, Israel

Location

Istituto Nazionale Tumori Fondazione Pascale ( Site 3903)

Napoli, 80131, Italy

Location

IRCCS Istituto Oncologico Veneto ( Site 3905)

Padua, 35128, Italy

Location

Policlinico Le Scotte - A.O. Senese ( Site 3907)

Siena, 53100, Italy

Location

National Cancer Center Hospital East ( Site 0014)

Kashiwa, Chiba, 277-8577, Japan

Location

Hyogo Cancer Center ( Site 0015)

Akashi, Hyōgo, 673-8558, Japan

Location

Canterbury District Health Board ( Site 0023)

Christchurch, Canterbury, 8011, New Zealand

Location

Auckland City Hospital ( Site 0016)

Auckland, 1023, New Zealand

Location

Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 4803)

Poznan, Greater Poland Voivodeship, 60-780, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 4801

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Sandton Oncology Medical Group PTY LTD ( Site 2701)

Johannesburg, Gauteng, 2196, South Africa

Location

Cape Town Oncology Trials Pty Ltd ( Site 2704)

Kraaifontein, Western Cape, 7570, South Africa

Location

Cancercare Rondebosch Oncology ( Site 2706)

Rondebosch, Western Cape, 7700, South Africa

Location

Asan Medical Center ( Site 0006)

Seoul, Seoul, 05505, South Korea

Location

Seoul National University Hospital ( Site 0007)

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 0008)

Seoul, 03722, South Korea

Location

Samsung Medical Center ( Site 0010)

Seoul, 06351, South Korea

Location

Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 3403)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 3405)

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Hospital General Universitario de Valencia ( Site 3404)

Valencia, Valenciana, Comunitat, 46014, Spain

Location

Hospital Clinic i Provincial de Barcelona ( Site 3401)

Barcelona, 08036, Spain

Location

Hospital Universitario Virgen de la Macarena ( Site 3402)

Seville, 41009, Spain

Location

Skanes Universitetssjukhus Lund. ( Site 4601)

Lund, Skåne County, 221 85, Sweden

Location

Related Publications (2)

• Perets R, Bar J, Rasco DW, Ahn MJ, Yoh K, Kim DW, Nagrial A, Satouchi M, Lee DH, Spigel DR, Kotasek D, Gutierrez M, Niu J, Siddiqi S, Li X, Cyrus J, Chackerian A, Chain A, Altura RA, Cho BC. Safety and efficacy of quavonlimab, a novel anti-CTLA-4 antibody (MK-1308), in combination with pembrolizumab in first-line advanced non-small-cell lung cancer. Ann Oncol. 2021 Mar;32(3):395-403. doi: 10.1016/j.annonc.2020.11.020. Epub 2020 Dec 2.

  PMID: 33276076 RESULT

• Cho BC, Yoh K, Perets R, Nagrial A, Spigel DR, Gutierrez M, Kim DW, Kotasek D, Rasco D, Niu J, Satouchi M, Ahn MJ, Lee DH, Maurice-Dror C, Siddiqi S, Ren Y, Altura RA, Bar J. Anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody quavonlimab in combination with pembrolizumab: Safety and efficacy from a phase I study in previously treated extensive-stage small cell lung cancer. Lung Cancer. 2021 Sep;159:162-170. doi: 10.1016/j.lungcan.2021.07.009. Epub 2021 Jul 18.

  PMID: 34371366 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 7, 2017
• Study Start: July 2, 2017
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

AU (8); PL (2); FR (5); CL (1); IL (3); JP (2); KR (4); ES (5); GR (1); ZA (3); US (5); IT (3); CA (5); SE (1); NZ (2); CN (3)