Summary

Eligibility
for people ages 18-120 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

Substudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.

Official Title

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma: Substudy 02A

Keywords

Melanoma receptor tyrosine kinase inhibitor programmed cell death 1 (PD-1, PD1) programmed cell death ligand 1 (PD-L1, PDL1) T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine receptor motif domains (TIGIT) Pembrolizumab Lenvatinib Pembrolizumab + MK-1308 + MK-7684 Pembrolizumab + MK-1308 + Lenvatinib

Eligibility

You can join if…

Open to people ages 18-120

  • Has histologically or cytologically confirmed melanoma
  • Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
  • Has progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies
  • Has submitted prestudy imaging
  • Has not received more than 3 lines of therapy for their advanced melanoma
  • Has provided a tumor biopsy
  • Male participants who receive lenvatinib are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 5 days after the last dose of lenvatinib; for male participants who only receive pembrolizumab, MK-1308, MK-7684, or a combination, no contraception measures are needed
  • Female participant are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) OR use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after the last dose of pembrolizumab, MK-1308, MK-7684 or 30 days after the last dose of lenvatinib, whichever occurs last
  • Has adequate organ function
  • Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia)

You CAN'T join if...

  • Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days before the first dose of study intervention
  • Has a known additional malignancy that is progressing or requires active treatment within the past 2 years
  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has ocular or mucosal melanoma
  • Has known hypersensitivity including previous clinically significant hypersensitivity reaction to treatment with another mAb
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years
  • Has an active infection requiring systemic therapy
  • Has known history of human immunodeficiency virus (HIV)
  • Has known history of hepatitis B
  • Has a history of (noninfectious) pneumonitis
  • Has a history of active tuberculosis (TB)
  • Has received prior systemic anticancer therapy within 4 weeks prior to randomization
  • Has received prior radiotherapy within 2 weeks of first dose of study intervention
  • Has had major surgery <3 weeks prior to first dose of study intervention
  • Has received a live vaccine within 30 days before the first dose of study intervention
  • Has participated in a study of an investigational agent within 4 weeks prior to the first dose of study intervention
  • Has had an allogeneic tissue/solid organ transplant
  • Has a pre-existing Grade ≥3 gastrointestinal fistula or nongastrointestinal fistula
  • Has radiographic evidence of encasement of invasion of major blood vessel or of intratumoral cavitation
  • Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study intervention
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention

Locations

  • UCLA Hematology & Oncology ( Site 1004) accepting new patients
    Los Angeles California 90095 United States
  • The Angeles Clinic and Research Institute ( Site 1009) accepting new patients
    Los Angeles California 90025 United States
  • Providence Saint John's Health Center ( Site 1010) accepting new patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme Corp.
ID
NCT04305041
Phase
Phase 1/2
Study Type
Interventional
Last Updated