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

NCT03834623 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MCC-19706
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Melanoma

Keywords

melanoma; skin

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate of CC-122 in Combination With Nivolumab

  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)

  Up to 52 weeks

Secondary Outcomes (4)

• Number of Participants Who Experience Treatment Related Adverse Events

  Up to 52 weeks

• Tumor Response

  Up to 52 weeks

• Progression Free Survival

  Up to 24 months

• Overall Survival

  Up to 24 months

Study Arms (1)

CC-122 Plus Nivolumab

EXPERIMENTAL

Participants 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.

Drug: CC-122; Drug: Nivolumab

Interventions

CC-122 DRUG

Oral CC-122 at 2 mg daily, 5 days out of 7

Also known as: Avadomide

CC-122 Plus Nivolumab

Nivolumab DRUG

240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle

Also known as: Opdivo

CC-122 Plus Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Bristol-Myers Squibb: collaborator
• Celgene Corporation: collaborator

Study Sites (1)

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione; Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Nikhil Khushalani, MD
• Organization: Moffitt Cancer Center

Nikhil.Khushalani@moffitt.org

813-745-3437

Study Officials

• Nikhil Khushalani, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 8, 2019
• Study Start: May 14, 2019
• Primary Completion: June 29, 2021
• Study Completion: August 4, 2021
• Last Updated: October 5, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09

Locations

US (1)