18 and older, any sex, with Neoplasms, Advanced. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With a Dose Limiting Toxicity (DLT)Primary· 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 abnorma
Group
Value
95% CI
MK-1966 70 mg+SD-101 1 mg
0.0
0.0 – 33.1
MK-1966 70 mg+SD-101 4 mg
0.0
0.0 – 33.1
MK-1966 210 mg+SD-101 4 mg
20.0
5.1 – 44.8
MK-1966 700 mg+SD-101 4 mg
0.0
0.0 – 41.5
Number of Participants With Adverse Events (AEs)Primary· 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 co
Group
Value
95% CI
MK-1966 70 mg+SD-101 1 mg
3
MK-1966 70 mg+SD-101 4 mg
3
MK-1966 210 mg+SD-101 4 mg
6
MK-1966 700 mg+SD-101 4 mg
2
Number of Participants Discontinuing Study Drug Due to AEsPrimary· 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.
Group
Value
95% CI
MK-1966 70 mg+SD-101 1 mg
0
MK-1966 70 mg+SD-101 4 mg
0
MK-1966 210 mg+SD-101 4 mg
1
MK-1966 700 mg+SD-101 4 mg
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
MK-1966 70 mg+SD-101 1 mg
Serious: 1/3 (33%)
Deaths: 1/3
MK-1966 70 mg+SD-101 4 mg
Serious: 1/3 (33%)
Deaths: 2/3
MK-1966 210 mg+SD-101 4 mg
Serious: 3/6 (50%)
Deaths: 5/6
MK-1966 700 mg+SD-101 4 mg
Serious: 1/2 (50%)
Deaths: 0/2
Serious adverse events (6 terms)
Reaction
System
MK-1966 70 mg+SD-101 1 mg
MK-1966 70 mg+SD-101 4 mg
MK-1966 210 mg+SD-101 4 mg
MK-1966 700 mg+SD-101 4 mg
Pyrexia
General disorders
—
—
—
—
Skin infection
Infections and infestations
—
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Hypotension
Vascular disorders
—
—
—
—
Other adverse events (81 terms — click to expand)
Reaction
System
MK-1966 70 mg+SD-101 1 mg
MK-1966 70 mg+SD-101 4 mg
MK-1966 210 mg+SD-101 4 mg
MK-1966 700 mg+SD-101 4 mg
Nausea
Gastrointestinal disorders
—
—
—
—
Fatigue
General disorders
—
—
—
—
Stomatitis
Gastrointestinal disorders
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
Chills
General disorders
—
—
—
—
Injection site reaction
General disorders
—
—
—
—
Mucosal inflammation
General disorders
—
—
—
—
Pyrexia
General disorders
—
—
—
—
Candida infection
Infections and infestations
—
—
—
—
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527
· Phase 1
· not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M
· Phase 3
· not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 4 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02731742.