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Immunomodulatory Agent

CC-122 for Melanoma

Phase 2
Waitlist Available
Led By Nikhil Khushalani, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to see if they're more effective at treating cancer and preventing T-cell exhaustion than current treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate of CC-122 in Combination With Nivolumab
Secondary outcome measures
Therapeutic procedure
Overall Survival
Progression Free Survival
+1 more

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619
36%
Vomiting
36%
Thrombocytopenia
36%
Nausea
27%
Fatigue
27%
Leukopenia
27%
Anaemia
27%
Hypokalaemia
18%
Hyperbilirubinaemia
18%
Neutropenia
18%
Rash
18%
Nasal discomfort
18%
Insomnia
18%
Musculoskeletal chest pain
18%
Hypomagnesaemia
9%
Squamous cell carcinoma of skin
9%
Blood alkaline phosphatase increased
9%
Encephalopathy
9%
Respiratory syncytial virus infection
9%
Upper respiratory tract infection
9%
Hypocalcaemia
9%
Ileus paralytic
9%
Enterocolitis
9%
Pyrexia
9%
Back pain
9%
Cellulitis
9%
Acute kidney injury
9%
Rash maculo-papular
9%
Abdominal pain
9%
Lymphopenia
9%
Pain
9%
Hypogammaglobulinaemia
9%
Cough
9%
Aspartate aminotransferase increased
9%
Hyponatraemia
9%
Headache
9%
Hypophosphataemia
9%
Dysphonia
9%
Oropharyngeal pain
9%
Hiatus hernia
9%
Arthralgia
9%
Nystagmus
9%
Sepsis
9%
Febrile neutropenia
9%
Bloody discharge
9%
Hypertension
9%
Neurotoxicity
9%
Acute respiratory failure
9%
Chapped lips
9%
Alanine aminotransferase increased
9%
Rhinorrhoea
9%
Pneumonia
9%
Asthenia
9%
Muscular weakness
9%
Abdominal pain upper
9%
Hypertriglyceridaemia
9%
Productive cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Trial Design

1Treatment groups
Experimental Treatment
Group I: CC-122 Plus NivolumabExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
CC-122
2015
Completed Phase 2
~670

Find a Location

Who is running the clinical trial?

Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,213 Total Patients Enrolled
9 Trials studying Melanoma
474 Patients Enrolled for Melanoma
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,459 Total Patients Enrolled
43 Trials studying Melanoma
3,195 Patients Enrolled for Melanoma
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,041 Total Patients Enrolled
177 Trials studying Melanoma
57,463 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Avadomide (CC-122) in Combination With Nivolumab in Advanced Melanoma
2019. "Avadomide (CC-122) in Combination With Nivolumab in Advanced Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03834623.
~4 spots leftby Apr 2025
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