Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001)

NCT03249792 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 2118-001MK-2118-001
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 8

Brief Summary

The purposes of this study are to: 1) assess the safety and tolerability and 2) establish a preliminary recommended Phase 2 dose (RP2D) and/or a maximum tolerated dose (MTD) or a maximum administered dose (MAD) of MK-2118 when administered via intratumoral (IT) injection as monotherapy and in combination with pembrolizumab (MK-3475) intravenous (IV) infusion, or via subcutaneous (SC) injection in combination with pembrolizumab IV infusion in the treatment of adult participants with advanced/metastatic solid tumors or lymphomas. Participants will receive either MK-2118 monotherapy or MK-2118 in combination with pembrolizumab for up to 35 cycles for Arms 1-3 or up to 36 cycles for Arm 4 (up to approximately 2 years). All participants will undergo at least a 24-hour observation period following the first three administrations of MK-2118 (Arms 1-3: Cycle 1 Days 1, 8, and 15. Arm 4: Cycle 1 Days 1 and 8; and Cycle 2 Day 1). Qualified participants who experience radiographic or clinical progression in Arm 1 (MK-2118 Intra-tumoral \[IT\] monotherapy) may switch over to Arm 2 (MK-2118 IT + Pembrolizumab IV Combination Therapy) at an eligible dose. Pharmacokinetic (PK) outcome measures will not be analyzed separately for the switch-over treatment arms, per protocol.

Conditions

Solid Tumor; Lymphoma

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Experience One or More Dose-limiting Toxicities (DLTs)

  A DLT is defined as the following toxicities, if related to study treatment: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia (Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding); non-hematologic adverse event (AE) ≥Grade 3 (with exceptions); Grade 3 or Grade 4 nonhematologic abnormality; febrile neutropenia Grade 3 or 4; any toxicity causing treatment discontinuation or missing ≥1 dose; any toxicity causing a \>2 week delay initiating pembrolizumab; any elevated aspartate aminotransferase or alanine aminotransferase value that is ≥3× upper limit of normal (ULN) and an elevated total bilirubin value that is ≥2× ULN \& an alkaline phosphatase value that is \<2× ULN with no alternative explanation; any ≥Grade 2 immune-mediated uveitis; Grade 5 toxicity. Per protocol, DLTs were analyzed separately for the switch-over treatment arms. The number of participants who experienced one or more DLTs is reported.

  Up to ~35 days

• Number of Participants Who Experience One or More Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, safety was analyzed separately for the switch-over treatment arms. The number of participants who experienced one or more AEs is reported.

  Up to ~65 months

• Number of Participants Who Discontinue Study Treatment Due to an AE

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, tolerability was analyzed separately for the switch-over treatment arms. The number of participants who discontinued study treatment due to an AE is reported.

  Up to ~27 months

Secondary Outcomes (4)

• MK-2118 Minimum Plasma Concentration (Cmin)

  Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours postdose; Cycle 2 Day 1, Cycle 3 Day 1: Predose, 0.5, 1, 2, 4, 6, 8 hours postdose (Arms 1 and 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 and 3= 3 weeks)

• MK-2118 Maximum Plasma Concentration (Cmax)

  Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours postdose; Cycle 2 Day 1, Cycle 3 Day 1: Predose, 0.5, 1, 2, 4, 6, 8 hours postdose (Arms 1 and 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 and 3= 3 weeks)

• MK-2118 Area Under the Concentration-time Curve From 0 to 24 Hours (AUC 0-24 Hours)

  Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours postdose; Cycle 2 Day 1, Cycle 3 Day 1: Predose, 0.5, 1, 2, 4, 6, 8 hours postdose (Arms 1 and 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 and 3= 3 weeks)

• Pembrolizumab Minimum Plasma Concentration (Cmin)

  Predose on Day 1 of Cycles 1, 2, 3, 4, 5 and every 4 cycles thereafter (up to ~2 years) (Arm 2: length of Cycle= 3 weeks, Arm 4: length of Cycle 1= 2 weeks, length of Cycles 2 to 36= 3 weeks)

Study Arms (25)

Arm 1 MK-2118 100 µg Intra-tumoral (IT) Monotherapy

EXPERIMENTAL

Participants receive MK-2118 100 µg via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT)

Arm 1 MK-2118 300 µg IT Monotherapy

EXPERIMENTAL

Participants receive MK-2118 300 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT)

Arm 1 MK-2118 900 µg IT Monotherapy

EXPERIMENTAL

Participants receive MK-2118 900 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT)

Arm 1 MK-2118 2700 µg IT Monotherapy

EXPERIMENTAL

Participants receive MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT)

Arm 1 MK-2118 5400 µg IT Monotherapy

EXPERIMENTAL

Participants receive MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT)

Arm 1 MK-2118 7700 µg IT Monotherapy

EXPERIMENTAL

Participants receive MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT)

Arm 1 MK-2118 10000 µg IT Monotherapy

EXPERIMENTAL

Participants receive MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT)

Arm 1 MK-2118 15000 µg IT Monotherapy

EXPERIMENTAL

Participants receive MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT)

Arm 1 MK-2118 20000 µg IT Monotherapy

EXPERIMENTAL

Participants receive MK-2118 20000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT)

Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 2700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT); Biological: Pembrolizumab

Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 5400 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT); Biological: Pembrolizumab

Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 7700 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT); Biological: Pembrolizumab

Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 10000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT); Biological: Pembrolizumab

Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 15000 µg via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by Q3W on Day 1 of Cycle 4 and beyond, for a total of up to \~35 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT); Biological: Pembrolizumab

(Not Enrolled) Arm 3 MK-2118 Visceral IT + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-2 followed by Q3W on Day 1 of Cycle 3 and beyond, for a total of up to \~35 cycles (up to \~2 years) and pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for a total of up to \~35 cycles (up to \~2 years). Each cycle is 3 weeks long.

Drug: MK-2118 (IT); Biological: Pembrolizumab

Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 5000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.

Drug: MK-2118 (SC); Biological: Pembrolizumab

Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 10000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.

Drug: MK-2118 (SC); Biological: Pembrolizumab

Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 15000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.

Drug: MK-2118 (SC); Biological: Pembrolizumab

Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 20000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.

Drug: MK-2118 (SC); Biological: Pembrolizumab

Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 30000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.

Drug: MK-2118 (SC); Biological: Pembrolizumab

Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 45000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.

Drug: MK-2118 (SC); Biological: Pembrolizumab

Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 60000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.

Drug: MK-2118 (SC); Biological: Pembrolizumab

Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 90000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.

Drug: MK-2118 (SC); Biological: Pembrolizumab

Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 120000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.

Drug: MK-2118 (SC); Biological: Pembrolizumab

Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

EXPERIMENTAL

Participants receive MK-2118 150000 µg via SC injection Q1W on Days 1 and 8 of Cycle 1 followed by Q1W on Days 1, 8 and 15 of Cycles 2-4, followed Q3W Day 1 of Cycle 5 and beyond, for a total of up to 36 cycles (up to \~2 years) and receive pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for a total of up to 36 cycles (up to \~2 years). Cycle 1 is 2 weeks long and Cycles 2 to 36 are 3 weeks long.

Drug: MK-2118 (SC); Biological: Pembrolizumab

Interventions

MK-2118 (IT) DRUG

IT injection

(Not Enrolled) Arm 3 MK-2118 Visceral IT + Pembrolizumab 200 mg IV Combination Therapy; Arm 1 MK-2118 100 µg Intra-tumoral (IT) Monotherapy; Arm 1 MK-2118 10000 µg IT Monotherapy; Arm 1 MK-2118 15000 µg IT Monotherapy; Arm 1 MK-2118 20000 µg IT Monotherapy; Arm 1 MK-2118 2700 µg IT Monotherapy; Arm 1 MK-2118 300 µg IT Monotherapy; Arm 1 MK-2118 5400 µg IT Monotherapy; Arm 1 MK-2118 7700 µg IT Monotherapy; Arm 1 MK-2118 900 µg IT Monotherapy; Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy; Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy; Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy; Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy; Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy

MK-2118 (SC) DRUG

SC injection

Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475

(Not Enrolled) Arm 3 MK-2118 Visceral IT + Pembrolizumab 200 mg IV Combination Therapy; Arm 2 MK-2118 10000 µg IT + Pembrolizumab 200 mg IV Combination Therapy; Arm 2 MK-2118 15000 µg IT + Pembrolizumab 200 mg IV Combination Therapy; Arm 2 MK-2118 2700 µg IT + Pembrolizumab 200 mg IV Combination Therapy; Arm 2 MK-2118 5400 µg IT + Pembrolizumab 200 mg IV Combination Therapy; Arm 2 MK-2118 7700 µg IT + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 10000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 120000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 15000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 150000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 20000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 30000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 45000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 5000 µg Subcutaneous (SC) + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 60000 µg SC + Pembrolizumab 200 mg IV Combination Therapy; Arm 4: MK-2118 90000 µg SC + Pembrolizumab 200 mg IV Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Arms 1 and 2 Participants:
• Has any histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received, or have been intolerant to all treatment known to confer clinical benefit. Solid tumors and lymphomas of any type are eligible for enrollment. For cutaneous T-cell lymphoma (CTCL), histopathological diagnosis should be confirmed in a skin biopsy representative of disease.
• Has Stage III or Stage IV disease that is not surgically resectable. Stage IIB (T3N0M0B0-1) CTCL participants are eligible.
• Arm 3 Participants:
• \- Has metastatic liver and/or liver lesion involvement that does not exceed one third of the total liver volume in participants to be treated by liver IT injection. Hepatocellular carcinoma participants are excluded from eligibility of IT liver injection.
• All Participants:
• Has Stage III or Stage IV disease that is not surgically resectable.
• Has ≥1 injectable lesion that is amenable to injection and biopsy via visual inspection for a cutaneous lesion, or via ultrasound guidance for a subcutaneous lesion.
• Has ≥1 discrete, distant noninjected lesion that is amenable to biopsy via visual inspection or amenable to biopsy via image guidance.
• Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Demonstrates adequate organ function.
• A male participant is eligible to participate if he agrees to the following during the intervention period and for at least 120 days after the last dose of study intervetnion:
• Refrain from donating sperm.
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

You may not qualify if:

• Has history of a second malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 2 years (except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer).
• Has clinically active central nervous system metastases and/or carcinomatous meningitis.
• Has severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb).
• Has active autoimmune disease that has required systemic treatment in the past 2 years.
• Has history of vasculitis.
• Has active infection requiring therapy.
• Has history of (noninfectious) pneumonitis that required steroids or current pneumonitis.
• Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
• Has known Hepatitis B or C infection.
• Has known psychiatric or substance abuse disorders that would interfere in cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
• Is not fully recovered from any effects of major surgery, and is free of significant detectable infection.
• HIV-infected participants with history of Kaposi's sarcoma and/or multicentric Castleman's disease.
• HIV-infected participants who have had an HIV-related opportunistic infection within 6 months.
• Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to the first dose of study treatment, or has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from the AEs due to cancer therapeutics administered \>4 weeks earlier.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (8)

University of California San Diego Moores Cancer Center ( Site 0004)

La Jolla, California, 92093, United States

Location

UCLA ( Site 0003)

Los Angeles, California, 90095, United States

Location

University of Chicago ( Site 0002)

Chicago, Illinois, 60637, United States

Location

New York Presbyterian Hospital/Columbia University ( Site 0001)

New York, New York, 10032, United States

Location

UPMC Hillman Cancer Centers ( Site 0007)

Pittsburgh, Pennsylvania, 15232, United States

Location

Mary Crowley Cancer Research Center ( Site 0005)

Dallas, Texas, 75230, United States

Location

MD Anderson Cancer Centr. ( Site 0006)

Houston, Texas, 77030, United States

Location

Sheba Medical Center ( Site 0301)

Ramat Gan, 5265601, Israel

Location

Related Publications (1)

• Luke JJ, Sweis RF, Hecht JR, Schneider R, Stein MN, Golan T, Yap TA, Khilnani A, Huang M, Zhao R, Jemielita T, Patel SP. Intratumoral or Subcutaneous MK-2118, a Noncyclic Dinucleotide STING Agonist, with or without Pembrolizumab, for Advanced or Metastatic Solid Tumors or Lymphomas. Clin Cancer Res. 2025 Apr 1;31(7):1233-1242. doi: 10.1158/1078-0432.CCR-24-2824.

  PMID: 39846804 RESULT

Related Links

• Merck Oncology Clinical Trials Information

MeSH Terms

Conditions

Lymphoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 15, 2017
• Study Start: September 20, 2017
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: July 24, 2025
• Results First Posted: July 24, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (7); IL (1)