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

NCT ID: NCT03179436

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-02
• Study Completion Date: 2024-04-08

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.

Detailed Description

After screening, participants will be assigned to the Dose Escalation, Dose Confirmation, Efficacy Expansion, or Coformulation Phase. The Dose Escalation Phase will evaluate available PK and safety data including dose limiting toxicities (DLTs). The Dose Confirmation Phase will gather additional safety, tolerability, PK, and preliminary efficacy data of quavonlimab in combination with pembrolizumab, and will include first-line advanced/metastatic non-small cell lung cancer (NSCLC) and second line (and beyond) advanced/metastatic small cell lung cancer (SCLC). The purpose of the Efficacy Expansion Phase is to gather preliminary anti-tumor efficacy data for quavonlimab in combination with pembrolizumab as well as for quavonlimab monotherapy in the specific target population of programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) refractory melanoma. The Coformulation Phase will evaluate the safety and PK of a coformulated product of pembrolizumab/quavonlimab (MK-1308A) in comparison to that of the single, co-administered products given at the same dose and schedule, and include participants with advanced solid tumors and participants from mainland China.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Quavonlimab

Intervention Type: 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.

Pembrolizumab

Intervention Type: 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).

Escalation: DL 2 Quavonlimab + Pembro: Cohort 2

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.

Group Type: EXPERIMENTAL

Quavonlimab

Intervention Type: 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.

Pembrolizumab

Intervention Type: 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).

Escalation: DL 3 Quavonlimab + Pembro: Cohort 3

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.

Group Type: EXPERIMENTAL

Quavonlimab

Intervention Type: 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.

Pembrolizumab

Intervention Type: 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).

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

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.

Group Type: EXPERIMENTAL

Quavonlimab

Intervention Type: 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.

Pembrolizumab

Intervention Type: 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).

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

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.

Group Type: EXPERIMENTAL

Quavonlimab

Intervention Type: 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.

Pembrolizumab

Intervention Type: 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).

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

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.

Group Type: EXPERIMENTAL

Quavonlimab

Intervention Type: 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.

Pembrolizumab

Intervention Type: 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).

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

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.

Group Type: EXPERIMENTAL

Quavonlimab

Intervention Type: 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.

Pembrolizumab

Intervention Type: 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).

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

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.

Group Type: EXPERIMENTAL

Quavonlimab

Intervention Type: 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.

Pembrolizumab

Intervention Type: 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).

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

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.

Group Type: EXPERIMENTAL

Quavonlimab

Intervention Type: 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.

Pembrolizumab

Intervention Type: 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).

Expansion: DL1 Quavonlimab Schedule 2 Monotherapy: Arm G

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).

Group Type: EXPERIMENTAL

Quavonlimab

Intervention Type: 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.

Coformulation: Pembrolizumab/Quavonlimab Schedule 2: Arm I

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.

Group Type: EXPERIMENTAL

Pembrolizumab/Quavonlimab

Intervention Type: DRUG

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

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

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.

Group Type: EXPERIMENTAL

Pembrolizumab/Quavonlimab

Intervention Type: DRUG

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

Interventions

Quavonlimab

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.

Intervention Type: BIOLOGICAL

Pembrolizumab

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).

Intervention Type: BIOLOGICAL

Pembrolizumab/Quavonlimab

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

Intervention Type: DRUG

Other Intervention Names

MK-1308; Keytruda®; MK-1308A

Eligibility Criteria

Inclusion Criteria

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:

• Have histologically/cytologically-confirmed unresectable Stage III or Stage IV melanoma per American Joint Committee on Cancer (AJCC) staging system version 8, not amenable to local therapy
• Have at least 1 measurable lesion by CT or MRI per RECIST 1.1 by BICR. Cutaneous lesions and other superficial lesions are not considered measurable lesions for the purposes of this protocol, but may be considered as non-target lesions
• Participants with unresectable Stage III or IV disease must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies (combinations with anti-cytotoxic T-lymphocyte associated protein 4 [CTLA-4] agents will not be allowed)
• Participants who receive anti-PD-1 therapy as adjuvant treatment following complete resection of Stage III or IV melanoma and have disease recurrence (unresectable loco-regional disease or distant metastases) while on active treatment or within 6 months of stopping anti-PD-1 are eligible
• Have submitted pre-trial imaging and provided a baseline tumor sample
• Proto-oncogene B-raf (BRAF) V600 mutation-positive melanoma participants should have received targeted therapy for advanced or metastatic disease (eg, BRAF/MEK inhibitor, alone or in combination) prior to enrolling on this study; however, they are not required to progress on this treatment prior to enrollment
• BRAF V600E mutation-positive melanoma participants who have NOT received a BRAF inhibitor (either as adjuvant therapy or in the metastatic disease setting) with lactate dehydrogenase (LDH) < local upper limit of normal (ULN), no clinically significant tumor-related symptoms, and absence of rapidly progressing metastatic melanoma. Approximately 10 participants each from Arms F and G will have 2 mandatory biopsies

For Dose Coformulation Phase Arm I:

• Have any histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and have received, been intolerant to, been ineligible for or refused all treatment known to confer clinical benefit
• Meet all requirements for Dose Escalation Phase and Dose Confirmation Phase

For the Coformulation Phase - Arm K (China only):

• Have any histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and have received, been intolerant to, been ineligible for, or refused all treatment known to confer clinical benefit
• Be a Chinese participant residing in China.

Exclusion Criteria

• 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
• Has received a live or live attenuated vaccine within 28 days of planned treatment start
• Has known history of human immunodeficiency virus (HIV) and/or known active Hepatitis B or C infections, and/or known to be positive for hepatitis B surface antigen (HBsAg)/ hepatitis B virus (HBV) DNA
• Has known psychiatric or substance abuse disorders that would interfere with the participant's ability to cooperate with the requirements of the trial
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with screening and for up to 120 days following cessation of pembrolizumab or pembrolizumab/quavonlimab
• Has not fully recovered from any effects of major surgery without significant detectable infection

For Arm F and G (Efficacy Expansion Phase) and Arm K (Coformulation Phase) ONLY:

• Has known active CNS metastases and/or carcinomatous meningitis
• Has not had resolution of anti-PD-1 antibody-related AEs, including immune-mediated AEs back to Grade ≤1 or baseline (not applicable to Arm K)
• Has not discontinued steroid treatment for an irAE for at least 2 weeks prior to the first dose of study drug (not applicable to Arm K)
• Has ocular melanoma (not applicable to Arm K)
• Has mucosal melanoma (not applicable to Arm K)
• Has had an allogenic tissue/solid organ transplant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Banner MD Anderson Cancer Center ( Site 0013)

Gilbert, Arizona, United States

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

Hackensack, New Jersey, United States

Tennessee Oncology Nashville ( Site 0004)

Nashville, Tennessee, United States

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

San Antonio, Texas, United States

Inova Schar Cancer Institute ( Site 1001)

Fairfax, Virginia, United States

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

Blacktown, New South Wales, Australia

Calvary Mater Newcastle ( Site 0025)

Waratah, New South Wales, Australia

Melanoma Institute Australia ( Site 0017)

Wollstonecraft, New South Wales, Australia

Gallipoli Medical Research Foundation-GMRF CTU ( Site 0019)

Brisbane, Queensland, Australia

Cairns and Hinterland Hospital and Health Service ( Site 0020)

Cairns, Queensland, Australia

Ashford Cancer Centre Research ( Site 0012)

Kurralta Park, South Australia, Australia

Ballarat Health Services ( Site 0022)

Ballarat, Victoria, Australia

Alfred Health ( Site 0018)

Melbourne, Victoria, Australia

Sunnybrook Research Institute ( Site 1103)

Toronto, Ontario, Canada

Princess Margaret Cancer Centre ( Site 1104)

Toronto, Ontario, Canada

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

Montreal, Quebec, Canada

Jewish General Hospital ( Site 1105)

Montreal, Quebec, Canada

McGill University Health Centre ( Site 1101)

Montreal, Quebec, Canada

Fundacion Arturo Lopez Perez ( Site 5601)

Santiago, Region M. de Santiago, Chile

Beijing Cancer hospital-Digestive Oncology ( Site 5001)

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital-Phase 1 Unite ( Site 5004)

Chongqing, Chongqing Municipality, China

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

Hangzhou, Zhejiang, China

Hopital La Timone ( Site 3303)

Marseille, Bouches-du-Rhone, France

Institut Bergonie ( Site 3306)

Bordeaux, Gironde, France

CHRU Lille - Hopital Claude Huriez ( Site 3302)

Lille, Nord, France

CH Lyon Sud Hospices Civils de Lyon ( Site 3307)

Pierre-Bénite, Rhone, France

Gustave Roussy ( Site 3305)

Villejuif, Val-de-Marne, France

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

Athens, Attica, Greece

Rambam Medical Center ( Site 0003)

Haifa, , Israel

Hadassah Ein Karem Hebrew University Medical Center ( Site 0021)

Jerusalem, , Israel

Sheba Medical Center - Cancer Center ( Site 0002)

Ramat Gan, , Israel

Istituto Nazionale Tumori Fondazione Pascale ( Site 3903)

Napoli, , Italy

IRCCS Istituto Oncologico Veneto ( Site 3905)

Padua, , Italy

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

Siena, , Italy

National Cancer Center Hospital East ( Site 0014)

Kashiwa, Chiba, Japan

Hyogo Cancer Center ( Site 0015)

Akashi, Hyōgo, Japan

Canterbury District Health Board ( Site 0023)

Christchurch, Canterbury, New Zealand

Auckland City Hospital ( Site 0016)

Auckland, , New Zealand

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

Poznan, Greater Poland Voivodeship, Poland

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

Warsaw, Masovian Voivodeship, Poland

Sandton Oncology Medical Group PTY LTD ( Site 2701)

Johannesburg, Gauteng, South Africa

Cape Town Oncology Trials Pty Ltd ( Site 2704)

Kraaifontein, Western Cape, South Africa

Cancercare Rondebosch Oncology ( Site 2706)

Rondebosch, Western Cape, South Africa

Asan Medical Center ( Site 0006)

Seoul, Seoul, South Korea

Seoul National University Hospital ( Site 0007)

Seoul, , South Korea

Severance Hospital Yonsei University Health System ( Site 0008)

Seoul, , South Korea

Samsung Medical Center ( Site 0010)

Seoul, , South Korea

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

L'Hospitalet de Llobregat, Barcelona, Spain

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 3405)

Donostia / San Sebastian, Gipuzkoa, Spain

Hospital General Universitario de Valencia ( Site 3404)

Valencia, Valenciana, Comunitat, Spain

Hospital Clinic i Provincial de Barcelona ( Site 3401)

Barcelona, , Spain

Hospital Universitario Virgen de la Macarena ( Site 3402)

Seville, , Spain

Skanes Universitetssjukhus Lund. ( Site 4601)

Lund, Skåne County, Sweden

Countries

United States; Australia; Canada; Chile; China; France; Greece; Israel; Italy; Japan; New Zealand; Poland; South Africa; South Korea; Spain; Sweden

References

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.

Reference Type: RESULT

PMID: 33276076 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34371366 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

MK-1308-001

Identifier Type: OTHER

Identifier Source: secondary_id

173820

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-003703-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1308-001

Identifier Type: -

Identifier Source: org_study_id