PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 26 June 2023
• Main ID: NCT03132636
• Date of registration: 24/04/2017
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals
• Public title: PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
• Scientific title: A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
• Date of first enrolment: June 29, 2017
• Target sample size: 138
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03132636
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, Canada, France, Germany, Greece, Italy, Spain, Switzerland, United States

Contacts

• Name: Clinical Trial Management
• Affiliation: Regeneron Pharmaceuticals

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Confirmed diagnosis of invasive BCC

- Progression of disease on hedgehog inhibitor (HHI) therapy or intolerance of prior HHI
therapy

- At least 1 measurable lesion

- =18 years of age

- Hepatic function, renal function, bone marrow function in defined lab-value-ranges

- Anticipated life expectancy >12 weeks

- Consent to provide archived tumor biopsy material (all patients)

- Group 2: consent to undergo research biopsies

- Group 2: must not be a candidate for radiation therapy or surgery

- Comply with study procedures and site visits

- Sign Subject Information Sheet and Informed Consent Form

Key Exclusion Criteria:

- Ongoing or recent significant autoimmune disease

- Prior treatment with specific pathway-blockers (PD-1/PD-L1)

- Prior treatment with immune-modulating agents within 28 days before cemiplimab

- Untreated brain metastasis that may be considered active

- Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to
treatment with cemiplimab

- Active infections requiring therapy, including HIV, hepatitis

- Pneumonitis within the last 5 years

- Cancer treatment other than radiation therapy, including investigational or standard
of care, within 30 days prior to treatment with cemiplimab

- Documented allergic reactions or similar to antibody treatments

- Concurrent malignancies other than BCC, other than those with negligible risk of
metastases or death

- Any acute or chronic psychiatric problems

- Having received a solid organ transplantation

- Inability to undergo contrast radiological assessments

- Breastfeeding, pregnant, women of childbearing potential not using contraception

Note: Other protocol-defined inclusion/exclusion criteria apply



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma, Basal Cell

Intervention(s)

Drug: cemiplimab

Primary Outcome(s)

Objective Response Rates (ORR) as Assessed by Independent Central Review (ICR) [Time Frame: Up to 1422 days]

Secondary Outcome(s)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [Time Frame: Up to 1422 days]

Duration of Response (DOR) Per ICR [Time Frame: Up to 40 months]

Overall Survival (OS) [Time Frame: Up to 40 months]

Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire [Time Frame: Baseline (Day 1 of Cycle 1); Day 1 of Cycles 2 to 9 (Cycles 1-5 [Each cycle of 9 weeks], Cycles 6 to 9 [Each cycle of 12 weeks])]

Serum Concentration at End of Infusion (Cmax) of Cemiplimab [Time Frame: At end-of-infusion (within 10 minutes after the end of infusion) on Cycle 1 Day 1 and Cycle 3 Day 1 (Each cycle of 9 weeks)]

Number of Participants With Anti-Drug Antibody (ADA) Status [Time Frame: Cycle 1: Days 1 and 43; Cycles 3 and 5: Day 1 (Each cycle of 9 weeks)]

Duration of Response (DOR) Per Investigator Assessment [Time Frame: Up to 40 months]

Percentage of Participants With Complete Response (CR) Rate Assessed by ICR [Time Frame: Up to 1422 days]

Progression Free Survival (PFS) Determined by Investigator Assessment [Time Frame: Up to 40 months]

Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [Time Frame: Baseline (Day 1 of Cycle 1); Day 1 of Cycles 2 to 9 (Cycles 1-5 [Each cycle of 9 weeks], Cycles 6 to 9 [Each cycle of 12 weeks])]

Progression Free Survival (PFS) Determined by ICR [Time Frame: Up to 40 months]

Serum Concentration at Pre-infusion (Ctrough) of Cemiplimab [Time Frame: At pre-infusion on Cycle 1 Day 22 and Cycle 3 Day 1 (Each cycle of 9 weeks)]

Secondary ID(s)

2016-003122-16

R2810-ONC-1620

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi

Results

• Results available: Yes
• Date Posted: 26/07/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03132636