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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03515824




Registration number
NCT03515824
Ethics application status
Date submitted
23/04/2018
Date registered
4/05/2018
Date last updated
9/03/2021

Titles & IDs
Public title
Study of MK-1697 in Participants With Advanced Solid Tumors (MK-1697-001)
Scientific title
A Phase 1 Study of MK-1697 in Participants With Advanced Solid Tumors
Secondary ID [1] 0 0
MK1697-001
Secondary ID [2] 0 0
1697-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Colorectal Neoplasms 0 0
Head and Neck Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MK-1697

Experimental: Part A: MK-1696 20 mg - Participants received 20 mg of MK-1697 by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).

Experimental: Part A: MK-1697 65 mg - Participants received 65 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).

Experimental: Part A: MK-1697 200 mg - Participants received 200 mg of MK-1697 by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).

Experimental: Part B: Expansion Cohort - Participants with select tumor types were to receive MK-1697 at the RP2D by IV infusion on Day 1 of each 21-day cycle for up to 35 administrations (up to approximately 2 years).


Other interventions: MK-1697
Administered by IV infusion on Day 1 of each 21-day cycle
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1
Timepoint [1] 0 0
Up to 21 days of Cycle 1 (cycle length = 21 days)
Primary outcome [2] 0 0
Number of Participants Who Experienced At Least One Adverse Event (AE)
Timepoint [2] 0 0
Up to approximately 9 months
Primary outcome [3] 0 0
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Timepoint [3] 0 0
Up to approximately 8 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Timepoint [1] 0 0
Up to approximately 18 months (through End of Trial data cut-off 18 Feb 2020)
Secondary outcome [2] 0 0
Objective Response Rate (ORR) Per Modified Response Evaluation Criteria In Solid Tumors Version 1.1 for Immune-based Therapeutics (iRECIST)
Timepoint [2] 0 0
Up to approximately 18 months (through End of Trial data cut-off 18 Feb 2020)
Secondary outcome [3] 0 0
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC 0-inf) of MK-1697
Timepoint [3] 0 0
Cycle 1-3: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days)
Secondary outcome [4] 0 0
Area Under the Concentration Time Curve From Time Zero to Last Concentration (AUC 0-last) Measured of MK-1697
Timepoint [4] 0 0
Cycles 1, 2, and 3: predose, 10 minutes and 2 hours post-dose (cycle length = 21 days)
Secondary outcome [5] 0 0
Maximum Serum Concentration (Cmax) of MK-1697
Timepoint [5] 0 0
Cycle 1-3: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days)
Secondary outcome [6] 0 0
Minimum Serum Concentration (Cmin) of MK-1697
Timepoint [6] 0 0
Cycles 1-3, 5, 7, 11: Days 1, 2 (only Cycle 1), 3, 8, 15 - predose and postdose at 10 minutes, 2 hours (cycle length = 21 days)

Eligibility
Key inclusion criteria
- For Part A; has a histologically- or cytologically-confirmed advanced/metastatic solid
tumor and has received, been intolerant to, or been ineligible for all treatments
known to confer clinical benefit

- For Part B: has 1 of the following histologically or cytologically confirmed tumor
types that are anti-programmed cell death protein 1 (anti PD-1)/anti-programmed
death-ligand 1 (anti PD-L1) treatment naive:

- CRC originating in either the colon or rectum that is locally advanced
unresectable or metastatic (ie, Stage IV) and that has received, and progressed
on, all available standard-of-care therapies including fluoropyrimidine,
oxaliplatin, and irinotecan

- HNSCC that is considered incurable by local therapies. The eligible primary tumor
locations are oropharynx, oral cavity, hypopharynx, and larynx. Participants may
not have a primary tumor site of nasopharynx (any histology). Also, participants
must have progressed after receiving platinum-containing systemic therapy

- Has measurable disease by Response Evaluation Criteria in Solid Tumors, version 1.1
(RECIST 1.1)

- Has an evaluable baseline tumor sample (either a recent or archival) for analysis

- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Has central venous access (eg, portacath, Hickman line, or peripherally inserted
central catheter [PICC] line) currently inserted or be considered medically fit for
and willing to undergo the insertion of such a device

- Is not pregnant or breastfeeding

- Female participants of childbearing potential must agree to use contraception during
the treatment period and for at least 120 days after the last dose of study treatment

- Male participants must agree to use contraception during the treatment period and for
at least 120 days after the last dose of study treatment and refrain from donating
sperm during this period
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has a history of a second malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 3 years with the exception of
participants who underwent successful definitive resection of basal cell carcinoma of
the skin, superficial bladder cancer or in situ cervical cancer, or other in-situ
cancers

- Has clinically active central nervous system (CNS) metastases and/or carcinomatous
meningitis

- Has had a severe hypersensitivity reaction to treatment with any monoclonal antibody
and/or components of the study treatment

- Has an active infection requiring therapy

- Has a history of interstitial lung disease

- Has a history of (noninfectious) pneumonitis that required steroids or current
pneumonitis

- Has an active autoimmune disease that has required systemic treatment in the past 2
years

- Has known human immunodeficiency virus (HIV) and/or Hepatitis B or C infections, or
known to be positive for Hepatitis B antigen/Hepatitis B virus deoxyribonucleic acid
(DNA) or Hepatitis C Antibody or ribonucleic acid (RNA)

- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with participation, make
administration of the study treatments hazardous, or make it difficult to monitor
adverse effects in the opinion of the treating investigator

- Has a history or current evidence of severe cardiovascular disease, ie, arrhythmias
requiring chronic treatment, congestive heart failure (New York Heart Association
[NYHA] Class III or IV) or symptomatic ischemic heart disease.

- Has a known psychiatric or substance abuse disorder 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 the screening visit through 120 days
after the last dose of study treatment

- Has not fully recovered from any effects of major surgery without significant
detectable infection. Surgeries that required general anesthesia must be completed at
least 2 weeks before first study treatment administration. Surgery requiring
regional/epidural anesthesia must be completed at least 72 hours before first study
treatment administration and participants should be recovered

- Has known microsatellite instability (MSI) high or mismatch repair genes (MMR)
deficient colorectal cancer. If a participant's MSI status is unknown, a paired blood
sample for MSI in addition to biomarker testing is required to determine MSI status
retrospectively (for the CRC expansion cohort only)

- Has a positive pregnancy test within 72 hours before the first dose of study treatment

- 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 Terminology Criteria for Adverse Events (CTCAE) Grade 1 or
better from any adverse events that were due to cancer therapeutics administered more
than 4 weeks earlier

- Has received prior therapy with an anti-Lymphocyte-activation gene 3 (LAG-3) agent

- Has received a live vaccine within 30 days prior to the first dose of study drug

- Has undergone a prior stem cell or bone marrow transplant within the last 5 years

- Is expected to require any other form of antineoplastic therapy while on study

- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose of
study treatment

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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/02/2020
Sample size
Target
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research ( Site 0100) - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and preliminary efficacy of MK-1697.
There are 2 parts in this study: dose escalation to determine the recommended phase 2 dose
(RP2D) and confirm the RP2D (Part A) and cohort expansion to determine preliminary efficacy
in participants with colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC)
(Part B). No formal hypothesis testing will be done in this study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03515824
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT03515824