Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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 and via subcutaneous (SC) injection in combination with pembrolizumab IV infusion in the treatment of adult participants with advanced/metastatic solid tumors or lymphomas.

Official Title

A Phase 1 Open-label, Multicenter Study of MK-2118 Administered by Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab or by Subcutaneous Injection in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors or Lymphomas

Details

Participants will receive either MK-2118 monotherapy or MK-2118 in combination with pembrolizumab for up to 35 cycles (approximately 2 years).

All participants will undergo an at least 24-hour observation period following the first dose administration of MK-2118 on Cycle 1, Day 1.

Keywords

Solid Tumor Lymphoma Pembrolizumab MK-2118

Eligibility

You can join if…

Open to people ages 18 years and up

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.
  • Have 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:

  • 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Demonstrates adequate organ function.
  • If of childbearing potential, must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of study treatment.
  • Human Immunodeficiency Virus (HIV) -infected participants must meet these additional criteria:
  • Have HIV-1 infection documented by laboratory test.
  • Have well-controlled HIV on anti-retroviral therapy (ART), defined as: 1) must have a CD4+ T-cell count >350 cells/mm3 at time of screening; 2) must have achieved and maintained virologic suppression defined as confirmed HIV ribonucleic acid (RNA) level <50 or below the lower limit of quantification(LLOQ) using the locally available assay at the time of screening and for ≥12 weeks prior to screening; and 3) must have been on a stable regimen, without changes in drugs or dose modification, for ≥4 weeks prior to study entry (Day 1).

You CAN'T join if...

  • 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).
  • Clinically active central nervous system metastases and/or carcinomatous meningitis.
  • Severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb).
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • History of vasculitis.
  • Active infection requiring therapy.
  • History of (noninfectious) pneumonitis that required steroids or current pneumonitis.
  • Undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
  • Known Hepatitis B or C infection.
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
  • 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.
  • 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.
  • Been treated within 2 weeks of Cycle 1 Day1 with any of the following: strong/moderate

Cytochrome P450 2C9 (CYP2C9) inhibitors, such as: amiodarone, felbamate, fluconazole,miconazole, piperine, oxandrolone, fluorouracil and its derivatives (combination drug tegafur/gimeracil/oteracil [TS-1], Uftoral [UFT], tegafur, carmofur, doxifluridine,capecitabine), sulfaphenazole, cyclosporine, bucurol, tienilic acid; UGT1A3 inhibitors(including ritonavir, quinidine, probenecid, and valproic acid); or strong carbonyl reductase (CBR) inhibitors (including quercetin, menadione, glycyrrhetinic acid, and flufenamic acid).

  • Currently participating and receiving study therapy or has participated in a study of an investigational agent and has received study therapy or has used an investigational device within 28 days of administration of MK-2118.
  • Expected to require any other form of antineoplastic therapy while on study.
  • On chronic systemic steroid therapy in excess of replacement doses (prednisone ≤10 mg/day is acceptable), or on any other form of immunosuppressive medication. For CTCL,continued use of either prednisone ≤10 mg/day or continued use of topical steroids is acceptable.
  • Received a live vaccine within 28 days prior to first dose.
  • Been treated with a stimulator of interferon genes (STING) agonist (eg, MK-1454,ADU-S100 [synthetic cyclic dinucleotide (CDN)]).
  • Has a history of re-irradiation for SCCHN at the projected injection site.
  • Has a tumor(s) in direct contact or encases a major blood vessel and has ulceration and/or fungation onto the skin surface at the projected injection site.

Locations

  • University of California San Diego Moores Cancer Center ( Site 0004) accepting new patients
    La Jolla California 92093 United States
  • Mary Crowley Cancer Research Center. ( Site 0005) accepting new patients
    Dallas Texas 75230 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme Corp.
ID
NCT03249792
Phase
Phase 1
Study Type
Interventional
Last Updated