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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03179436
Ethics application status
Date submitted
31/05/2017
Date registered
7/06/2017
Date last updated
24/09/2020

Titles & IDs
Public title
Safety, Pharmacokinetics (PK), and Efficacy of 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] 0 0
MK-1308-001
Secondary ID [2] 0 0
1308-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MK-1308
Other interventions - Pembrolizumab
Treatment: Drugs - MK-1308A

Experimental: Escalation: Dose Level (DL) 1 MK-1308 + 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 MK-1308 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 MK-1308 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 MK-1308 + 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 MK-1308 at DL2. On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive MK-1308 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 MK-1308 + 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 MK-1308 at DL3. On Cycle 2, Day 1, and for 3 subsequent cycles on Day 1 (Cycles 3 to 5), these participants receive MK-1308 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 MK-1308 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 MK-1308 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 MK-1308 Schedule 2 + Pembro (NSCLC): Arm B - On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with NSCLC receive MK-1308 at DL1 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and MK-1308 at DL1 according to Schedule 2. Participants will be treated for up to 35 cycles total on study.

Experimental: Confirmation: DL 2 MK-1308 Schedule 2 + Pembro (NSCLC): Arm C - On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with NSCLC receive MK-1308 at DL2 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and MK-1308 at DL2 according to Schedule 2. Participants will be treated for up to 35 cycles total on study.

Experimental: Confirmation: DL 2 MK-1308 Schedule 2 + Pembro (SCLC): Arm D - On Cycle 1, Day 1 of the Dose Confirmation Phase, participants with SCLC receive MK-1308 at DL2 in combination with pembrolizumab at PDL1. On all subsequent cycles, participants receive pembrolizumab at PDL1 according to Schedule 1 and MK-1308 at DL2 according to Schedule 2. Participants will be treated for up to 35 cycles total on study.

Experimental: Confirmation: DL 2 MK-1308 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 MK-1308 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 MK-1308 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 melanoma receive MK-1308 at DL1 in combination with pembrolizumab at pembrolizumab dose level 2 (PDL2). Both MK-1308 and pembrolizumab will be administered according to Schedule 2 for up to 24 months on study.

Experimental: Expansion: DL1 MK-1308 Schedule 2 Monotherapy: Arm G - On Cycle 1, Day 1 of the Efficacy Expansion Phase and during all subsequent cycles, participants with melanoma receive MK-1308 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: MK-1308A 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 MK-1308A according to Schedule 2 for up to 24 months on study.


Other interventions: MK-1308
MK-1308 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.

Other interventions: 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: MK-1308A
MK-1308A is a coformulated product composed of MK-1308 at DL1 in combination with pembrolizumab at dose level 2 (PDL2).

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with a Dose Limiting Toxicity (DLT) - 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] 0 0
Up to 6 weeks
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to approximately 2.5 years
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Up to approximately 2 years
Primary outcome [4] 0 0
Coformulation Phase: Number of participants with =1 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.
Timepoint [4] 0 0
Up to approximately 2.5 years
Primary outcome [5] 0 0
Coformulation Phase: 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.
Timepoint [5] 0 0
Up to approximately 2 years
Primary outcome [6] 0 0
Efficacy Expansion: Number of participants with =1 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.
Timepoint [6] 0 0
Up to approximately 2.5 years
Primary outcome [7] 0 0
Efficacy Expansion: 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
Timepoint [7] 0 0
Up to approximately 2 years
Primary outcome [8] 0 0
Efficacy Expansion: Objective Response Rate (ORR) as assessed by blinded independent central review (BICR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - 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 modified RECIST 1.1. Tumor responses evaluated using modified 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 modified 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 modified 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 [8] 0 0
Up to approximately 4 years
Secondary outcome [1] 0 0
Dose Escalation: Area under the plasma concentration time curve (AUC) of MK-1308 at steady state - AUC is the area under the plot of plasma concentration of drug against time after drug administration and is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs. Blood samples will be collected at multiple time points during the Dose Escalation phase to assess the AUC of MK-1308.
Timepoint [1] 0 0
Cycles 1, 2 and 3: end of infusion (up to approximately 30 minutes), Day 8, and Day 15. Cycles 5 and 9: end of infusion (up to 30 minutes). Cycle = 21 days
Secondary outcome [2] 0 0
Dose Escalation: Minimum concentration (Cmin) of MK-1308 at steady state - 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) during the Dose Escalation phase to assess the Cmin of MK-1308.
Timepoint [2] 0 0
Pre-dose Cycles 1, 2, 3, 5, 6, 7, 9 and every 4 cycles up to 2 years. Cycle = 21 days
Secondary outcome [3] 0 0
Dose Escalation: Maximum concentration (Cmax) of MK-1308 at steady state - Cmax is the maximum or "peak" concentration of a drug observed after its administration. Blood samples will be collected at multiple time points during the Dose Escalation phase to assess the Cmax of MK-1308.
Timepoint [3] 0 0
Cycles 1, 2 and 3: end of infusion (up to approximately 30 minutes), Day 8, and Day 15. Cycles 5 and 9: end of infusion (up to 30 minutes). Cycle = 21 days
Secondary outcome [4] 0 0
Dose Confirmation: AUC of MK-1308 at steady state - AUC is the area under the plot of plasma concentration of drug against time after drug administration and is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs. Blood samples will be collected at multiple time points during the Dose Confirmation phase to assess the AUC of MK-1308.
Timepoint [4] 0 0
Cycles 1, 2, 3: end of infusion (up to approximately 30 minutes), Day 8, and Day 15. Cycle 4 and 8: end of infusion (up to 30 minutes). Cycle = 21 days
Secondary outcome [5] 0 0
Dose Confirmation: Cmin of MK-1308 at steady state - 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) during the Dose Confirmation phase to assess the Cmin of MK-1308.
Timepoint [5] 0 0
Pre-dose cycles 1, 2, 3, 4, 5, 6, 8, and every 4 cycles up to 2 years. Cycle = 21 days
Secondary outcome [6] 0 0
Dose Confirmation: Cmax of MK-1308 at steady state - Cmax is the maximum or "peak" concentration of a drug observed after its administration. Blood samples will be collected at multiple time points during the Dose Confirmation phase to assess the Cmax of MK-1308.
Timepoint [6] 0 0
Cycles 1, 2, 3: end of infusion (up to approximately 30 minutes), Day 8, and Day 15. Cycle 4 and 8: end of infusion (up to 30 minutes). Cycle = 21 days
Secondary outcome [7] 0 0
Dose Escalation, Dose Confirmation, and Coformulation: ORR as assessed by investigator based on modified RECIST 1.1 - 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 modified RECIST 1.1. Tumor responses evaluated using modified 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 modified 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 modified 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 [7] 0 0
Up to approximately 4 years
Secondary outcome [8] 0 0
Efficacy Expansion: Duration of Response (DOR) as assessed by BICR based on modified RECIST 1.1 - DOR was 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 [8] 0 0
Up to approximately 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

- Female participants of childbearing potential must have negative urine or serum
pregnancy test within 72 hours prior to receiving the first dose of study treatment
and 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

- 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. 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 Stage 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 may 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

- 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

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 only:

- 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 MK-1308.

- 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) ONLY:

- 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 non-infectious 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-virus 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 study medication(s)

- Has not fully recovered from any effects of major surgery without significant
detectable infection

For Efficacy Expansion Phase Arms (F and G) 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

- Has not discontinued steroid treatment for an irAE for at least 2 weeks prior to the
first dose of study drug

- Has ocular melanoma

- 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/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital. Western Sydney local health district ( Site 0009) - Blacktown
Recruitment hospital [2] 0 0
Calvary Mater Newcastle ( Site 0025) - Waratah
Recruitment hospital [3] 0 0
Melanoma Institute Australia ( Site 0017) - Wollstonecraft
Recruitment hospital [4] 0 0
Cairns and Hinterland Hospital and Health Service ( Site 0020) - Cairns
Recruitment hospital [5] 0 0
Greenslopes Private Hospital ( Site 0019) - Greenslopes
Recruitment hospital [6] 0 0
Ashford Cancer Centre Research ( Site 0012) - Kurralta Park
Recruitment hospital [7] 0 0
Ballarat Health Services ( Site 0022) - Ballarat
Recruitment hospital [8] 0 0
Alfred Health ( Site 0018) - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [4] 0 0
4870 - Cairns
Recruitment postcode(s) [5] 0 0
4120 - Greenslopes
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
3350 - Ballarat
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Chile
State/province [7] 0 0
Region M. De Santiago
Country [8] 0 0
France
State/province [8] 0 0
Bouches-du-Rhone
Country [9] 0 0
France
State/province [9] 0 0
Gironde
Country [10] 0 0
France
State/province [10] 0 0
Nord
Country [11] 0 0
France
State/province [11] 0 0
Rhone
Country [12] 0 0
France
State/province [12] 0 0
Val-de-Marne
Country [13] 0 0
Greece
State/province [13] 0 0
Attiki
Country [14] 0 0
Israel
State/province [14] 0 0
HaMerkaz
Country [15] 0 0
Israel
State/province [15] 0 0
Yerushalayim
Country [16] 0 0
Israel
State/province [16] 0 0
Haifa
Country [17] 0 0
Italy
State/province [17] 0 0
Padova
Country [18] 0 0
Italy
State/province [18] 0 0
Siena
Country [19] 0 0
Japan
State/province [19] 0 0
Chiba
Country [20] 0 0
Japan
State/province [20] 0 0
Hyogo
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
New Zealand
State/province [22] 0 0
Canterbury
Country [23] 0 0
New Zealand
State/province [23] 0 0
Auckland
Country [24] 0 0
Poland
State/province [24] 0 0
Mazowieckie
Country [25] 0 0
Poland
State/province [25] 0 0
Wielkopolskie
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Gipuzkoa
Country [28] 0 0
Spain
State/province [28] 0 0
Valenciana, Comunitat
Country [29] 0 0
Spain
State/province [29] 0 0
Sevilla
Country [30] 0 0
Sweden
State/province [30] 0 0
Skane Lan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
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 MK-1308 when used in combination with pembrolizumab in
participants with advanced solid tumors.
Trial website
https://clinicaltrials.gov/show/NCT03179436
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@merck.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03179436