Neoplasms, AdvancedPhase 1NCT02731742

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

A Phase 1 study testing MK-1966 and SD-101 in people with Neoplasms, Advanced, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms, Advanced
What is being tested?: MK-1966 and SD-101
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: No sites listed yet
Study dates: 22 Jun 2016to 8 Jan 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 19Show fewer

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

About this study

Official title: A Phase 1/1b Trial of MK-1966 in Combination With SD-101 in Subjects With Advanced Malignancies

This was a non-randomized, open-label study of MK-1966 used in combination with SD-101 in the treatment of advanced malignancies. The study included an initial Dose Evaluation phase (Part A) to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) by evaluating Dose Limiting Toxicities (DLTs) of four dose combinations of MK-1966 and SD-101. Following determination of the MTD/MAD, approximately 20 participants each were to be enrolled in two expansion cohorts (Parts B or C) to confirm/refine the MTD/MAD. The study was terminated by the Sponsor before enrollment into Part A concluded and before enrollment into Parts B and C began.

Conditions: Neoplasms, Advanced
Being tested: MK-1966, SD-101
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-1966Biological
MK-1966 administered as an intravenous (IV) infusion
SD-101Drug
SD-101 administered as an intratumoral (IT) injection

Study groups in NCT02731742
Study group	Role	What they receive
Dose A MK-1966 + Dose A SD-101	Experimental	Participants received 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 were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days. Receives: Biological: MK-1966; Drug: SD-101
Dose A MK-1966 + Dose B SD-101	Experimental	Participants received 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 were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days. Receives: Biological: MK-1966; Drug: SD-101
Dose B MK-1966 + Dose B SD-101	Experimental	Participants received 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 were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days. Receives: Biological: MK-1966; Drug: SD-101
Dose C MK-1966 + Dose B SD-101	Experimental	Participants received 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 were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days. Receives: Biological: MK-1966; Drug: SD-101
Part B Expansion Cohort	Experimental	Participants were to receive the MTD/MAD of MK-1966 and SD-101 established in Part A for up to 7 additional treatment cycles with MK-1966 and up to 6 additional treatment cycles with SD-101. Each cycle was to be 21 days. Receives: Biological: MK-1966; Drug: SD-101
Part C Expansion Cohort	Experimental	Participants were to receive the MTD/MAD of MK-1966 and SD-101 established in Part A for up to 7 additional treatment cycles with MK-1966 and 6 additional treatment cycles with SD-101. Each cycle was to be 21 days. Receives: Biological: MK-1966; Drug: SD-101

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a Dose Limiting Toxicity (DLT)
The occurrence of any of the following toxicities during Cycle 1 (Days 1-21), if assessed by the Investigator to be possibly, probably or definitely related to MK-1966 or SD-101, was considered a DLT:
1. Grade (Gr) 4 non-hematologic toxicity;
2. Gr 4 hematologic toxicity lasting >7 days, except thrombocytopenia: *Gr 4 thrombocytopenia of any duration; *Gr 3 thrombocytopenia if associated with bleeding;
3. Gr 3 non-hematologic toxicity lasting >3 days despite optimal supportive care;
4. Any Gr 3 or Gr 4 non-hematologic laboratory abnormality, if: medical intervention is required OR abnormality leads to hospitalization OR abnormality persists for >1 week;
5. Febrile neutropenia Gr 3 or Gr 4;
6. Any drug-related AE which caused participant to discontinue study drug during Cycle 1
7. Gr 5 toxicity; or
8. Delay in initiation of Cycle 2 for >2 weeks due to study drug-related toxicity. The percentage of participants who experienced a DLT during Cycle 1 is presented.
Measured: From time of first dose of study drug to the end of Cycle 1. Each cycle was 21 days. (Up to 21 days)
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study drug, was also an AE. The number of participants who experienced as AE is presented.
Measured: From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks)
Number of Participants Discontinuing Study Drug Due to AEs
The number of participants who discontinued study drug due to an AE is presented.
Measured: From first dose of study drug up to last dose of study drug (Up to approximately 9 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 20168 Jan 2018

First posted7 Apr 2016 (estimated)
Study start22 Jun 2016
Primary completion8 Jan 2018
Study completion8 Jan 2018

Why it stopped: The study was terminated early due to business reasons.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Neoplasms, AdvancedStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02731742
Sponsor's protocol ID: 1966-001
Other IDs: MK-1966-001
Status last verified: Sep 2018
First submitted: 4 Apr 2016
Last updated: 4 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitationPhase 2
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Neoplasms

All Neoplasms, Advanced trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/1b Trial of MK-1966 in Combination With SD-101 in Subjects With Advanced Malignancies
ClinicalTrials.gov ID: NCT02731742
Acronym / sponsor ID: 1966-001
Conditions: Neoplasms, Advanced
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated early due to business reasons.
Enrolment: 14 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 22 Jun 2016 (actual)
Primary completion: 8 Jan 2018 (actual)
Study completion: 8 Jan 2018 (actual)
First posted: 7 Apr 2016 (estimated)
Results: Posted 4 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Dose A MK-1966 + Dose A SD-101	Experimental	Biological: MK-1966, Drug: SD-101Participants received 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 were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days.
Dose A MK-1966 + Dose B SD-101	Experimental	Biological: MK-1966, Drug: SD-101Participants received 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 were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days.
Dose B MK-1966 + Dose B SD-101	Experimental	Biological: MK-1966, Drug: SD-101Participants received 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 were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days.
Dose C MK-1966 + Dose B SD-101	Experimental	Biological: MK-1966, Drug: SD-101Participants received 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 were to continue in one of two expansion cohorts (Part B or C) and receive up to 8 cycles of treatment (approximately 24 weeks). Each cycle was 21 days.
Part B Expansion Cohort	Experimental	Biological: MK-1966, Drug: SD-101Participants were to receive the MTD/MAD of MK-1966 and SD-101 established in Part A for up to 7 additional treatment cycles with MK-1966 and up to 6 additional treatment cycles with SD-101. Each cycle was to be 21 days.
Part C Expansion Cohort	Experimental	Biological: MK-1966, Drug: SD-101Participants were to receive the MTD/MAD of MK-1966 and SD-101 established in Part A for up to 7 additional treatment cycles with MK-1966 and 6 additional treatment cycles with SD-101. Each cycle was to be 21 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-1966MK-1966 administered as an intravenous (IV) infusion	Biological	Dose A MK-1966 + Dose A SD-101, Dose A MK-1966 + Dose B SD-101, Dose B MK-1966 + Dose B SD-101, Dose C MK-1966 + Dose B SD-101, Part B Expansion Cohort, Part C Expansion Cohort
SD-101SD-101 administered as an intratumoral (IT) injection	Drug	Dose A MK-1966 + Dose A SD-101, Dose A MK-1966 + Dose B SD-101, Dose B MK-1966 + Dose B SD-101, Dose C MK-1966 + Dose B SD-101, Part B Expansion Cohort, Part C Expansion Cohort

Primary outcome

Percentage of Participants With a Dose Limiting Toxicity (DLT)
Time frame: From time of first dose of study drug to the end of Cycle 1. Each cycle was 21 days. (Up to 21 days)
The occurrence of any of the following toxicities during Cycle 1 (Days 1-21), if assessed by the Investigator to be possibly, probably or definitely related to MK-1966 or SD-101, was considered a DLT: 1. Grade (Gr) 4 non-hematologic toxicity; 2. Gr 4 hematologic toxicity lasting >7 days, except thrombocytopenia: *Gr 4 thrombocytopenia of any duration; *Gr 3 thrombocytopenia if associated with bleeding; 3. Gr 3 non-hematologic toxicity lasting >3 days despite optimal supportive care; 4. Any Gr 3 or Gr 4 non-hematologic laboratory abnormality, if: medical intervention is required OR abnormality leads to hospitalization OR abnormality persists for >1 week; 5. Febrile neutropenia Gr 3 or Gr 4; 6. Any drug-related AE which caused participant to discontinue study drug during Cycle 1 7. Gr 5 toxicity; or 8. Delay in initiation of Cycle 2 for >2 weeks due to study drug-related toxicity. The percentage of participants who experienced a DLT during Cycle 1 is presented.
Number of Participants With Adverse Events (AEs)
Time frame: From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks)
An AE was defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study drug, was also an AE. The number of participants who experienced as AE is presented.
Number of Participants Discontinuing Study Drug Due to AEs
Time frame: From first dose of study drug up to last dose of study drug (Up to approximately 9 weeks)
The number of participants who discontinued study drug due to an AE is presented.

Results and safety

Results posted to the registry on 4 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-1966 70 mg+SD-101 1 mg	3	0
MK-1966 70 mg+SD-101 4 mg	3	0
MK-1966 210 mg+SD-101 4 mg	6	0
MK-1966 700 mg+SD-101 4 mg	2	0

Primary outcome: Percentage of Participants With a Dose Limiting Toxicity (DLT)

Time frame: From time of first dose of study drug to the end of Cycle 1. Each cycle was 21 days. (Up to 21 days). Number (80% Confidence Interval). Unit: Percentage of Participants

Measure	MK-1966 70 mg+SD-101 1 mg n = 3	MK-1966 70 mg+SD-101 4 mg n = 3	MK-1966 210 mg+SD-101 4 mg n = 5	MK-1966 700 mg+SD-101 4 mg n = 2
Value	0.0 (0.0 to 33.1)	0.0 (0.0 to 33.1)	20.0 (5.1 to 44.8)	0.0 (0.0 to 41.5)

Population analysed: The DLT evaluable population consisted of all participants who completed study drug in Cycle 1 or discontinued study drug during Cycle 1 due to a DLT.

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks). Count of participants. Unit: Participants

Measure	MK-1966 70 mg+SD-101 1 mg n = 3	MK-1966 70 mg+SD-101 4 mg n = 3	MK-1966 210 mg+SD-101 4 mg n = 6	MK-1966 700 mg+SD-101 4 mg n = 2
Value	3	3	6	2

Population analysed: The safety analysis population consisted of all participants who received ≥1 dose of study drug.

Primary outcome: Number of Participants Discontinuing Study Drug Due to AEs

Time frame: From first dose of study drug up to last dose of study drug (Up to approximately 9 weeks). Count of participants. Unit: Participants

Measure	MK-1966 70 mg+SD-101 1 mg n = 3	MK-1966 70 mg+SD-101 4 mg n = 3	MK-1966 210 mg+SD-101 4 mg n = 6	MK-1966 700 mg+SD-101 4 mg n = 2
Value	0	0	1	0

Population analysed: The safety analysis population consisted of all participants who received ≥1 dose of study drug.

Adverse events

Time frame: From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-1966 70 mg+SD-101 1 mg	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
MK-1966 70 mg+SD-101 4 mg	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
MK-1966 210 mg+SD-101 4 mg	3 of 6 (50%)	6 of 6 (100%)	5 of 6
MK-1966 700 mg+SD-101 4 mg	1 of 2 (50%)	2 of 2 (100%)	0 of 2

Limitations and caveats (from the sponsor): The study was terminated early due to business reasons.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-1966 and SD-101 in people with Neoplasms, Advanced, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Dose Limiting Toxicity (DLT) (time frame: From time of first dose of study drug to the end of Cycle 1. Each cycle was 21 days. (Up to 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02731742.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.