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Clinical Trial 21344

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT05116202

Phase: Phase I/II
Principal Investigator: Tarhini, Ahmad

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or 1-800-679-0775 Learn More
Overview

Study Title

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients with Melanoma (Morpheus-Melanoma)

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.

Objective

pRR (defined as the proportion of patients with pCR, pnCR, and pPR) at time of surgery, as determined by independent pathologic review. 2. pRR (defined as the proportion of patients with pCR, pnCR, and pPR) at time of surgery, as determined by local pathologic assessment 3. EFS, defined as the time from randomization to any of the following events (whichever occurs first): Disease progression that precludes surgery, as assessed by the investigator according to RECIST v1.1; local, regional or distant disease recurrence; or death from any cause 4.RFS, defined as the time from surgery to the first documented recurrence of disease or death from any cause 5.OS, defined as the time from randomization to death from any cause 6. ORR, defined as the proportion of patients with a CR or PR as determined by the investigator according to RECIST v1.1, prior to surgery

Treatments

Therapies

Immunotherapy; Therapy (NOS)

Medications

Atezolizumab (Tecentriq); BMS-936558 (Nivolumab); Ipilimumab (); Nivolumab (Opdivo); RO7247669 (); Tiragolumab (); Yervoy (Ipilimumab)

Inclusion Criteria

  • Inclusion Criteria for Cohort 1:
  • Histologically confirmed resectable Stage III melanoma according to AJCC-8 and no history of in-transit metastases within the last 6 months
  • Fit and planned for CLND
  • Measurable disease according to RECIST v1.1
  • Availability of a representative tumor specimen
  • Adequate hematologic and end-organ function
  • For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
  • Negative HIV test, negative hepatitis B surface antibody (HBsAb), and negative total hepatitis B core antibody (HBcAb) test, and negative hepatitis C virus (HCV) at screening
  • Inclusion Criteria for Cohort 2:
  • Life expectancy >= 3 months, as determined by the investigator
  • Histologically confirmed Stage IV (metastatic) cutaneous melanoma according to AJCC-8
  • Disease progression during or following at least one but no more than two lines of treatment for metastatic disease
  • Measurable disease according to RECIST v1.1
  • Availability of a representative tumor specimen
  • Adequate hematologic and end-organ function
  • For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
  • Negative HIV test, negative hepatitis B surface antibody (HBsAb), and negative total hepatitis B core antibody (HBcAb) test, and negative hepatitis C virus (HCV) at screening.

  • Exclusion Criteria

  • Exclusion Criteria for Cohort 1:
  • Mucosal, uveal and acral lentiginous melanoma
  • Distantly metastasized melanoma
  • History of in-transit metastases within the last 6 months
  • Prior radiotherapy
  • Prior immunotherapy, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, and other systemic therapy for melanoma
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
  • Prior allogeneic stem cell or solid organ transplantation
  • Known immunodeficiency or conditions requiring treatment with systemic immunosuppressive medication, or anticipation of need for systemic immunosuppressant medication during study treatment
  • Active or history of autoimmune disease or immune deficiency
  • Exclusion Criteria for Cohort 2:
  • Mucosal and uveal melanoma
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
  • Prior allogeneic stem cell or solid organ transplantation
  • Known immunodeficiency or conditions requiring treatment with systemic immunosuppressive medication, or anticipation of need for systemic immunosuppressant medication during study treatment
  • Active or history of autoimmune disease or immune deficiency
  • Symptomatic, untreated, or progressing CNS metastases
  • Active or history of carcinomatous meningitis/leptomeningeal disease
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Uncontrolled or symptomatic hypercalcemia

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.