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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03179436

Registration number

NCT03179436

Ethics application status

Date submitted

31/05/2017

Date registered

7/06/2017

Titles & IDs

Public title

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

Scientific title

A Phase 1 / 2 Open Label, Multi-Arm, Multicenter Study of MK-1308 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Secondary ID [1]

MK-1308-001

Secondary ID [2]

1308-001

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Advanced Solid Tumors

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Other - Quavonlimab
Treatment: Other - Pembrolizumab
Treatment: Drugs - Pembrolizumab/Quavonlimab

Experimental: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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).

Experimental: 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.

Experimental: 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.

Treatment: Other: 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.

Treatment: Other: 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).

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

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Number of participants with a Dose Limiting Toxicity (DLT)

Assessment method [1]

DLTs will be assessed during the first 6 weeks (2 cycles) of treatment for the Dose Escalation and the first 3 weeks (1 cycle) of treatment for the Dose Confirmation. DLT is 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.

Timepoint [1]

Up to 6 weeks

Primary outcome [2]

Number of participants with =1 adverse event (AE)

Assessment method [2]

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.

Timepoint [2]

Up to ~2.5 years

Primary outcome [3]

Number of participants discontinuing study treatment due to an AE

Assessment method [3]

Timepoint [3]

Up to ~2 years

Primary outcome [4]

Efficacy Expansion: Number of participants with =1 AE

Assessment method [4]

Timepoint [4]

Up to ~2.5 years

Primary outcome [5]

Efficacy Expansion: Number of participants discontinuing study treatment due to an AE

Assessment method [5]

Timepoint [5]

Up to ~2 years

Primary outcome [6]

Coformulation: Number of participants with =1 DLT

Assessment method [6]

DLTs will be assessed during the first 6 weeks of treatment for the Coformulation Phase (Arm I). A DLT is 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 of the Coformulation Phase 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.

Timepoint [6]

Up to 6 weeks

Primary outcome [7]

Coformulation: Number of participants with =1 AE

Assessment method [7]

Timepoint [7]

Up to ~2.5 years

Primary outcome [8]

Coformulation: Number of participants discontinuing study treatment due to an AE

Assessment method [8]

Timepoint [8]

Up to ~2 years

Primary outcome [9]

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)

Assessment method [9]

ORR is defined as the percentage of participants in the analysis population whose best overall response (BOR) is confirmed complete response (CR) or partial response (PR) as assessed by BICR and based on imaging per adjusted RECIST 1.1. Tumor responses evaluated using adjusted RECIST 1.1 follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ and require confirmation per RECIST 1.1. According to adjusted RECIST 1.1, CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR according to adjusted RECIST 1.1 is at least a 30% decrease in the sum of diameters (SOD) of target lesions as assessed by the investigator, taking as reference the baseline SOD.

Timepoint [9]

Up to ~4 years

Secondary outcome [1]

Area under the plasma concentration time curve (AUC) of pembrolizumab

Assessment method [1]

AUC is the area under the plot of plasma concentration of drug against time after drug administration. Blood samples will be collected at multiple time points to assess the AUC of pembrolizumab.

Timepoint [1]

At designated timepoints (up to ~6 months)

Secondary outcome [2]

Maximum concentration (Cmax) of pembrolizumab

Assessment method [2]

Cmax is the maximum or "peak" concentration of a drug observed after its administration. Blood samples will be collected at multiple time points to assess the Cmax of pembrolizumab.

Timepoint [2]

At designated timepoints (up to ~6 months)

Secondary outcome [3]

Minimum concentration (Cmin) of pembrolizumab

Assessment method [3]

Cmin is the minimum or "trough" concentration of a drug observed after its administration and just prior to the administration of a subsequent dose. Blood samples will be collected at multiple time points (pre-dose) to assess the Cmin of pembrolizumab.

Timepoint [3]

At designated timepoints (up to ~6 months)

Secondary outcome [4]

Number of participants with pembrolizumab anti-drug antibodies (ADAs)

Assessment method [4]

Blood samples will be collected at designated time points for the determination of the presence or absence of pembrolizumab ADAs. The number of participants who develop pembrolizumab ADAs will be reported.

Timepoint [4]

At designated timepoints (up to ~2 years)

Secondary outcome [5]

AUC of quavonlimab

Assessment method [5]

AUC is the area under the plot of plasma concentration of drug against time after drug administration. Blood samples will be collected at multiple time points to assess the AUC of quavonlimab.

Timepoint [5]

At designated timepoints (up to ~6 months)

Secondary outcome [6]

Cmax of quavonlimab

Assessment method [6]

Cmax is the maximum or "peak" concentration of a drug observed after its administration. Blood samples will be collected at multiple time points to assess the Cmax of quavonlimab.

Timepoint [6]

At designated timepoints (up to ~6 months)

Secondary outcome [7]

Cmin of quavonlimab

Assessment method [7]

Timepoint [7]

At designated timepoints (up to ~6 months)

Secondary outcome [8]

Number of participants with quavonlimab ADAs

Assessment method [8]

Blood samples will be collected at designated time points for the determination of the presence or absence of quavonlimab ADAs. The number of participants who develop quavonlimab ADAs will be reported.

Timepoint [8]

At designated timepoints (up to ~2 years)

Secondary outcome [9]

Chinese Cohort: AUC of pembrolizumab

Assessment method [9]

AUC is the area under the plot of plasma concentration of drug against time after drug administration. Blood samples will be collected at multiple time points to assess the AUC of pembrolizumab.

Timepoint [9]

At designated timepoints (up to ~6 months)

Secondary outcome [10]

Chinese Cohort: Cmax of pembrolizumab

Assessment method [10]

Cmax is the maximum or "peak" concentration of a drug observed after its administration. Blood samples will be collected at multiple time points to assess the Cmax of pembrolizumab.

Timepoint [10]

At designated timepoints (up to ~6 months)

Secondary outcome [11]

Chinese Cohort: Cmin of pembrolizumab

Assessment method [11]

Timepoint [11]

At designated timepoints (up to ~6 months)

Secondary outcome [12]

Chinese Cohort: Number of participants with pembrolizumab ADAs

Assessment method [12]

Timepoint [12]

At designated timepoints (up to ~2 years)

Secondary outcome [13]

Chinese Cohort: AUC of quavonlimab

Assessment method [13]

AUC is the area under the plot of plasma concentration of drug against time after drug administration. Blood samples will be collected at multiple time points to assess the AUC of quavonlimab.

Timepoint [13]

At designated timepoints (up to ~6 months)

Secondary outcome [14]

Chinese Cohort: Cmax of quavonlimab

Assessment method [14]

Cmax is the maximum or "peak" concentration of a drug observed after its administration. Blood samples will be collected at multiple time points to assess the Cmax of quavonlimab.

Timepoint [14]

At designated timepoints (up to ~6 months)

Secondary outcome [15]

Chinese Cohort: Cmin of quavonlimab

Assessment method [15]

Timepoint [15]

At designated timepoints (up to ~6 months)

Secondary outcome [16]

Chinese Cohort: Number of participants with quavonlimab ADAs

Assessment method [16]

Timepoint [16]

At designated timepoints (up to ~2 years)

Secondary outcome [17]

Dose Escalation, Dose Confirmation, Coformulation: ORR as assessed by investigator based on adjusted RECIST v1.1

Assessment method [17]

ORR is defined as the percentage of participants in the analysis population whose BOR is confirmed CR or PR as assessed by investigator and based on imaging per adjusted RECIST 1.1. Tumor responses evaluated using adjusted RECIST 1.1 follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ and require confirmation per RECIST 1.1. According to adjusted RECIST 1.1, CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR according to adjusted RECIST 1.1 is at least a 30% decrease in the SOD of target lesions as assessed by the investigator, taking as reference the baseline SOD.

Timepoint [17]

Up to ~4 years

Secondary outcome [18]

Efficacy Expansion: Duration of Response (DOR) as assessed by BICR based on adjusted RECIST v1.1

Assessment method [18]

DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first (for responders only).

Timepoint [18]

Up to ~4 years

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

2/07/2017

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

8/04/2024

Sample size

Target

Accrual to date

Final

413

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,VIC

Recruitment hospital [1]

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

Recruitment hospital [2]

Calvary Mater Newcastle ( Site 0025) - Waratah

Recruitment hospital [3]

Melanoma Institute Australia ( Site 0017) - Wollstonecraft

Recruitment hospital [4]

Gallipoli Medical Research Foundation-GMRF CTU ( Site 0019) - Brisbane

Recruitment hospital [5]

Cairns and Hinterland Hospital and Health Service ( Site 0020) - Cairns

Recruitment hospital [6]

Ashford Cancer Centre Research ( Site 0012) - Kurralta Park

Recruitment hospital [7]

Ballarat Health Services ( Site 0022) - Ballarat

Recruitment hospital [8]

Alfred Health ( Site 0018) - Melbourne

Recruitment postcode(s) [1]

2148 - Blacktown

Recruitment postcode(s) [2]

2298 - Waratah

Recruitment postcode(s) [3]

2065 - Wollstonecraft

Recruitment postcode(s) [4]

4120 - Brisbane

Recruitment postcode(s) [5]

4870 - Cairns

Recruitment postcode(s) [6]

5037 - Kurralta Park

Recruitment postcode(s) [7]

3350 - Ballarat

Recruitment postcode(s) [8]

3004 - Melbourne

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Arizona

Country [2]

United States of America

State/province [2]

New Jersey

Country [3]

United States of America

State/province [3]

Tennessee

Country [4]

United States of America

State/province [4]

Texas

Country [5]

United States of America

State/province [5]

Virginia

Country [6]

Canada

State/province [6]

Ontario

Country [7]

Canada

State/province [7]

Quebec

Country [8]

Chile

State/province [8]

Region M. De Santiago

Country [9]

China

State/province [9]

Beijing

Country [10]

China

State/province [10]

Chongqing

Country [11]

China

State/province [11]

Zhejiang

Country [12]

France

State/province [12]

Bouches-du-Rhone

Country [13]

France

State/province [13]

Gironde

Country [14]

France

State/province [14]

Nord

Country [15]

France

State/province [15]

Rhone

Country [16]

France

State/province [16]

Val-de-Marne

Country [17]

Greece

State/province [17]

Attiki

Country [18]

Israel

State/province [18]

Haifa

Country [19]

Israel

State/province [19]

Jerusalem

Country [20]

Israel

State/province [20]

Ramat-Gan

Country [21]

Italy

State/province [21]

Napoli

Country [22]

Italy

State/province [22]

Padova

Country [23]

Italy

State/province [23]

Siena

Country [24]

Japan

State/province [24]

Chiba

Country [25]

Japan

State/province [25]

Hyogo

Country [26]

Korea, Republic of

State/province [26]

Seoul

Country [27]

New Zealand

State/province [27]

Canterbury

Country [28]

New Zealand

State/province [28]

Auckland

Country [29]

Poland

State/province [29]

Mazowieckie

Country [30]

Poland

State/province [30]

Wielkopolskie

Country [31]

South Africa

State/province [31]

Gauteng

Country [32]

South Africa

State/province [32]

Western Cape

Country [33]

Spain

State/province [33]

Barcelona

Country [34]

Spain

State/province [34]

Gipuzkoa

Country [35]

Spain

State/province [35]

Valenciana, Comunitat

Country [36]

Spain

State/province [36]

Sevilla

Country [37]

Sweden

State/province [37]

Skane Lan

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Merck Sharp & Dohme LLC

Country

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT03179436

Trial related presentations / publications

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.
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.

Public notes

Contacts

Principal investigator

Name

Medical Director

Address

Merck Sharp & Dohme LLC

Country

Phone

Contact person for public queries

Name

Address

Country

Phone

Contact person for scientific queries

Data sharing statement

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Type	Citations or Other Details
Journal	Perets R, Bar J, Rasco DW, Ahn MJ, Yoh K, Kim DW, ... [More Details]
Journal	Cho BC, Yoh K, Perets R, Nagrial A, Spigel DR, Gut... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT03179436

Register a trial

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03179436