Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Melanoma

What is the Purpose of this Study?

Substudies 02A, 02B, and 02C: To assess the safety and tolerability of investigational treatment combinations based on the proportion of participants with adverse events (AEs). Substudies 02A and 02B: To evaluate objective response rate (ORR) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). Substudy 02C: To evaluate pathological complete response (pCR) rate as assessed by central review of the pathology results.


Eligibility

  • Has histologically or cytologically confirmed melanoma
  • Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
  • Has been untreated for advanced disease.
  • Has provided a tumor biopsy
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Where can I participate?

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute : Saba Mukarram

More about this Clinical Trial

What is the full name of this clinical trial?

MK-3475-U02-01: 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: Master

Study Details
Disease Type/Condition

Melanoma, Soft Tissue

Principal Investigator

Hamid, Omid

Co-Investigators

Ani Balmanoukian, Cathie T Chung, Inderjit Mehmi, Iryna Singh, Justin Moyers, Kristopher Wentzel, Mark Faries, Navid Hafez

Age Group

Adult

Phase

I/II

IRB Number

STUDY00000595

ClinicalTrials.gov ID

NCT04305054

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Saba Mukarram

Phone
+1 310-231-2181
Email
MukarramS@cshs.org
Study Detail
Disease Type/Condition

Melanoma, Soft Tissue

Principal Investigator

Hamid, Omid

Age Group

Adult

Phase

I/II

IRB Number

MK-3475-U02-01

ClinicalTrials.gov ID

NCT04305054

Key Eligibility
ClinicalTrials.gov

Contact
Name

Saba Mukarram

Phone
+1 310-231-2181
Email
MukarramS@cshs.org