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Dose Evaluation of MK-1966 in Combination With SD-101 in Participants With Advanced Malignancies (MK-1966-001)

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ClinicalTrials.gov Identifier: NCT02731742
Recruitment Status : Terminated
First Posted : April 7, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a non-randomized, open-label study of MK-1966 used in combination with SD-101 in the treatment of advanced malignancies. The study will include an initial Dose Evaluation phase to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) by evaluating Dose Limiting Toxicities (DLTs) on four dose combinations of MK-1966 and SD-101. Following determination of the MTD/MAD, approximately 20 participants each will be enrolled in two expansion cohorts to confirm/refine the MTD/MAD.

Condition or disease Intervention/treatment Phase
Neoplasms, Advanced Biological: MK-1966 Drug: SD-101 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b Trial of MK-1966 in Combination With SD-101 in Subjects With Advanced Malignancies
Actual Study Start Date : June 22, 2016
Actual Primary Completion Date : January 8, 2018
Actual Study Completion Date : January 8, 2018

Arm Intervention/treatment
Experimental: Dose A MK-1966 + Dose A SD-101
Participants will receive a combination of MK-1966 (Days 1 and 21) and SD-101 (Days 1, 8, 15 and Day 22) in Part A of the study (approximately 21 days). Participants will continue in one of two expansion cohorts (Part B or C) and may receive up to 8 cycles of treatment (approximately 24 weeks).
Biological: MK-1966
MK-1966 administered as an intravenous (IV) infusion

Drug: SD-101
SD-101 administered intratumorally

Experimental: Dose A MK-1966 + Dose B SD-101
Participants will receive a combination of MK-1966 (Days 1 and 21) and SD-101 (Days 1, 8, 15 and Day 22) in Part A of the study (approximately 21 days). Participants will continue in one of two expansion cohorts (Part B or C) and may receive up to 8 cycles of treatment (approximately 24 weeks).
Biological: MK-1966
MK-1966 administered as an intravenous (IV) infusion

Drug: SD-101
SD-101 administered intratumorally

Experimental: Dose B MK-1966 + Dose B SD-101
Participants will receive a combination of MK-1966 (Days 1 and 21) and SD-101 (Days 1, 8, 15 and Day 22) in Part A of the study (approximately 21 days). Participants will continue in one of two expansion cohorts (Part B or C) and may receive up to 8 cycles of treatment (approximately 24 weeks).
Biological: MK-1966
MK-1966 administered as an intravenous (IV) infusion

Drug: SD-101
SD-101 administered intratumorally

Experimental: Dose C MK-1966 + Dose B SD-101
Participants will receive a combination of MK-1966 (Days 1 and 21) and SD-101 (Days 1, 8, 15 and Day 22) in Part A of the study (approximately 21 days). Participants will continue in one of two expansion cohorts (Part B or C) and may receive up to 8 cycles of treatment (approximately 24 weeks).
Biological: MK-1966
MK-1966 administered as an intravenous (IV) infusion

Drug: SD-101
SD-101 administered intratumorally

Experimental: Part B Expansion Cohort
Participants will receive the MTD/MAD of MK-1966 and SD-101 established in Part A for 7 additional treatment regimens with MK-1966 and 6 additional treatment regimens with SD-101.
Biological: MK-1966
MK-1966 administered as an intravenous (IV) infusion

Drug: SD-101
SD-101 administered intratumorally

Experimental: Part C Expansion Cohort
Participants will receive the MTD/MAD of MK-1966 and SD-101 established in Part A for 7 additional treatment regimens with MK-1966 and 6 additional treatment regimens with SD-101.
Biological: MK-1966
MK-1966 administered as an intravenous (IV) infusion

Drug: SD-101
SD-101 administered intratumorally




Primary Outcome Measures :
  1. Percentage of Participants with a Dose Limiting Toxicity (DLT) [ Time Frame: From time of first dose up to the end of Cycle 1 (up to 21 days) ]
  2. Number of Participants with Adverse Events (AEs) [ Time Frame: From time of first dose until the end of follow-up (up to 29 weeks) ]
  3. Number of Participants Discontinuing Study Drug Due to AEs [ Time Frame: From time of first dose until the end of follow-up (up to 24 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a histologically- or cytologically-confirmed advanced malignancy that has progressed after standard-of-care therapy/treatments and there is no available therapy likely to convey clinical benefit
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Has a life expectancy ≥ 6 months
  • Female participants must not be pregnant (negative urine or serum human chorionic gonadotropin test at screening and again within 72 hours prior to receiving the first dose of study therapy)
  • Female and male participants of reproductive potential must agree to use adequate contraception during the course of the study through 120 days after study the last dose of study therapy
  • Has ability to submit archived or fresh tumor sample during the screening period

Exclusion Criteria:

  • Has had chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study therapy, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier
  • Has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days of study start
  • Is expected to require any other form of antineoplastic therapy while on study
  • Is on chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication
  • Has a history of a malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has had a severe hypersensitivity reaction to treatment with another monoclonal antibody
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has an active infection requiring therapy
  • Has active, current pneumonitis, or a history of (non-infectious) pneumonitis that required steroids
  • Has had a prior stem cell or bone marrow transplant
  • Is positive for Human Immunodeficiency Virus (HIV) and/or Hepatitis B or C
  • Has known psychiatric disorder that would interfere with fulfilling the requirements of the study
  • Is a regular user of any illicit drugs or had a recent history of substance abuse
  • Has symptomatic ascites or pleural effusion
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study
  • Has clinically significant heart disease that affects normal activities
  • Has had major surgery (requiring at least a 3 day hospital stay) in the past 28 days
  • Has received a live vaccine within 30 days prior to first dose of study therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731742


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02731742     History of Changes
Other Study ID Numbers: 1966-001
MK-1966-001 ( Other Identifier: Merck Registration Number )
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018