Clinical Trials /

Avadomide (CC-122) in Combination With Nivolumab in Advanced Melanoma

NCT03834623

Description:

This study is to find out if the combination of CC-122 (an investigational agent) and Nivolumab will enhance the anti-cancer activity and prevent T-cell exhaustion (T-cells are responsible for maintaining the body's immune response).

Related Conditions:
  • Conjunctival Melanoma
  • Cutaneous Melanoma
  • Melanoma of Unknown Primary
  • Mucosal Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Avadomide (CC-122) in Combination With Nivolumab in Advanced Melanoma
  • Official Title: A Phase II Biomarker Trial of Avadomide (CC-122) in Combination With Nivolumab in Advanced Melanoma

Clinical Trial IDs

  • ORG STUDY ID: MCC-19706
  • NCT ID: NCT03834623

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
CC-122AvadomideCC-122 Plus Nivolumab
NivolumabOpdivoCC-122 Plus Nivolumab

Purpose

This study is to find out if the combination of CC-122 (an investigational agent) and Nivolumab will enhance the anti-cancer activity and prevent T-cell exhaustion (T-cells are responsible for maintaining the body's immune response).

Trial Arms

NameTypeDescriptionInterventions
CC-122 Plus NivolumabExperimentalParticipants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle.
  • CC-122
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          -  Unresectable or metastatic melanoma of cutaneous, mucosal, conjunctival, or unknown
             origin. Uveal melanoma is not permitted. Cohort 1: Naïve to anti-PD1 therapy Cohort 2:
             Progressed on previous anti-PD1 therapy. Subjects who have received anti-PD1 therapy
             in the adjuvant setting for previously resected melanoma are eligible for this cohort
             provided they have not received any intervening systemic therapy for the relapse

          -  Be willing and able to provide written informed consent for the trial.

          -  Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST)
             version 1.1

          -  Females of childbearing potential should have a negative urine or serum pregnancy test
             within 72 hours prior to receiving the first dose of study medication.

          -  Females of childbearing potential should be willing to use 2 methods of birth control
             or be surgically sterile, or abstain from heterosexual activity for the course of the
             study 28 days after last dose of avadomide or 5 months after the last dose of
             nivolumab, whichever is longer. Females of childbearing potential are those who have
             not been surgically sterilized or have not been free from menses for >1 year.

          -  Males should agree to use an adequate method of contraception starting with the first
             dose of study therapy through 3 months after the last dose of avadomide or 7 months
             after last dose of nivolumab, whichever is longer.

          -  Adequate organ function

        Exclusion Criteria:

          -  Has received an investigational drug or other anti-cancer therapy within 3 weeks of
             the first dose of treatment or < 5 half-lives of that agent, whichever is shorter. Any
             toxicity from prior therapy must have recovered to < grade 1.

          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
             other form of immunosuppressive therapy within 7 days prior to the first dose of trial
             treatment (only exception to this is the need for steroids for CNS metastases; see #6
             below). Inhaled, intra-articular, or topical steroids are permissible.

          -  Has a history of hypersensitivity to nivolumab.

          -  Has a known additional malignancy that is progressing or requires active treatment,
             the lack of which would pose a risk to the health of the subject, in the opinion of
             the investigator.

          -  Has known symptomatic central nervous system (CNS) metastases and/or carcinomatous
             meningitis. Subjects with previously treated brain metastases may participate provided
             they are stable without evidence of progression by imaging for at least four weeks
             after definitive intervention and using no more than the equivalent of dexamethasone
             2mg/d for the management of vasogenic edema, if necessary. This exception does not
             include carcinomatous meningitis, which is excluded regardless of clinical stability.

          -  Active autoimmune disease that has required systemic treatment in the past 2 years
             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
             drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
             replacement therapy [</= 10 mg/d equivalent of prednisone] for adrenal or pituitary
             insufficiency, etc.) is not considered a form of systemic treatment. Patients with
             previous grade III/IV toxicity from immunotherapy that led to treatment
             discontinuation are excluded.

          -  Has an active infection requiring systemic therapy.

          -  Has known psychiatric or substance abuse disorders that would interfere with
             cooperation with the requirements of the trial, in the opinion of the investigator.

          -  Is pregnant or breastfeeding.

          -  Has a known history of Human Immunodeficiency Virus (HIV), active Hepatitis B or
             Hepatitis C.

          -  Has received a live vaccine within 30 days of planned start of study therapy. Note:
             Seasonal influenza vaccines for injection are generally inactivated flu vaccines and
             are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live
             attenuated vaccines, and are not allowed
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate of CC-122 in combination with Nivolumab
Time Frame:Up to 36 months
Safety Issue:
Description:Objective Response Rate of CC-122 in combination with Nivolumab in both anti-PD1 therapy naive advanced melanoma as well as anti-PD1 therapy refractory melanoma (primary refractory or progressing after an initial response or stable disease)

Secondary Outcome Measures

Measure:Number of Participants who Experience Treatment Related Adverse Events
Time Frame:Up to 52 weeks
Safety Issue:
Description:All Adverse Events and Serious Adverse events will be collected and collated according to grade and frequency. This will include all events considered possibly, probably or definitely related to study therapy.
Measure:Tumor Response
Time Frame:Up to 52 weeks
Safety Issue:
Description:Tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and and iRECIST (Response Evaluation Criteria in Solid Tumors in immunotherapy)
Measure:Progression Free Survival
Time Frame:Up to 52 weeks
Safety Issue:
Description:Progression free survival will be calculated from the start of study therapy till the first documentation of disease progression, death, or change of treatment. Subjects receiving ongoing therapy at the time of data analysis will be censored
Measure:Overall Survival
Time Frame:Up to 36 months
Safety Issue:
Description:Overall survival will be calculated from the start of therapy till death from any cause. Subjects alive at the time of data analysis will be censored.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • melanoma
  • skin

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