REGN7075 in Combination With Cemiplimab in Adult Participants With Advanced Solid Tumors (COMBINE-EGFR-1)

• ClinicalTrials.gov Identifier: NCT04626635
• Recruitment Status: Recruiting
• First Posted: November 12, 2020
• Last Update Posted: January 13, 2023
• Sponsor: Regeneron Pharmaceuticals
• Information provided by (Responsible Party): Regeneron Pharmaceuticals

Tracking Information

• First Submitted Date: November 6, 2020
• First Posted Date: November 12, 2020
• Last Update Posted Date: January 13, 2023
• Actual Study Start Date: December 21, 2020
• Estimated Primary Completion Date: April 3, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 6, 2020)

• The incidence of dose-limiting toxicities (DLTs) during the DLT period [ Time Frame: Up to 6 weeks ]
  Dose escalation
• Incidence and severity of treatment emergent adverse events (TEAEs) [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose escalation
• Incidence and severity of adverse events of special interest (AESIs) [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose escalation
• Incidence and severity of serious adverse events (SAEs) [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose escalation
• Incidence and severity of grade ≥3 laboratory abnormalities [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose escalation
• Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]
  Dose expansion

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 21, 2022)

• Drug concentrations of REGN7075 in serum [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• Drug concentrations of cemiplimab [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• ORR [ Time Frame: Up to 5 years ]
  Dose escalation
• Progression free survival (PFS) [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• Duration of Response (DOR) [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• Disease control rate (DCR) [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• Complete response (CR) rate [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• Overall survival (OS) [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• Incidence of anti-drug antibodies (ADA) to REGN7075 [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose escalation and dose expansion
• Incidence of ADA to cemiplimab [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose escalation and dose expansion
• The incidence and severity of TEAEs [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose expansion
• The incidence and severity of AESIs [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose expansion
• The incidence and severity of SAEs [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose expansion
• The incidence and severity of grade ≥3 laboratory abnormalities [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose expansion
• Patient reported Quality of Life (QoL) per EORTC QLQ-C30 [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
• Patient reported Quality of Life (QoL) per EORTC QLQ-CR29 in CRC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
• Patient reported Quality of Life (QoL) per EORTC QLQ-BR23 in breast cancer patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC-QLQ-BR23 includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions use 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transforme to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
• Patient reported Quality of Life (QoL) per EORTC QLQ-LC13 in NSCLC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC QLQ-LC13 is a 13-item, disease-specific module which assesses quality of life across multiple scales, including dyspnea, cough and chest pain. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".
• Patient reported Quality of Life (QoL) per EORTC QLQ-HN35 in HNSCC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC QLQ-HN35 is a 35-item, disease-specific module which assesses quality of life across multiple scales, including pain, swallowing, and senses. The questionnaire has 35 Likert type questions in total and the evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.
• Patient reported Quality of Life (QoL) per EQ-5D-5L [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
• Patient reported symptoms per EORTC QLQ-C30 [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
• Patient reported symptoms per EORTC QLQ-CR29 in CRC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). . Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
• Patient reported symptoms per EORTC QLQ-BR23 in breast cancer patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC-QLQ-BR23 includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions use 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transforme to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
• Patient reported symptoms per EORTC QLQ-LC13 in NSCLC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC QLQ-LC13 is a 13-item, disease-specific module which assesses quality of life across multiple scales, including dyspnea, cough and chest pain. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".
• Patient reported symptoms per EORTC QLQ-HN35 in HNSCC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC QLQ-HN35 is a 35-item, disease-specific module which assesses quality of life across multiple scales, including pain, swallowing, and senses. The questionnaire has 35 Likert type questions in total and the evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.
• Patient reported symptoms per EQ-5D-5L [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
• Patient reported functioning per EORTC QLQ-C30 [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
• Patient reported functioning per EORTC QLQ-CR29 in CRC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
• Patient reported functioning per EORTC QLQ-BR23 in breast cancer patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC-QLQ-BR23 includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions use 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transforme to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
• Patient reported functioning per EORTC QLQ-LC13 in NSCLC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC QLQ-LC13 is a 13-item, disease-specific module which assesses quality of life across multiple scales, including dyspnea, cough and chest pain. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".
• Patient reported functioning per EORTC QLQ-HN35 in HNSCC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC QLQ-HN35 is a 35-item, disease-specific module which assesses quality of life across multiple scales, including pain, swallowing, and senses. The questionnaire has 35 Likert type questions in total and the evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.
• Patient reported functioning per EQ-5D-5L [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
• Patient reporting general health status per EORTC QLQ-C30 [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
• Patient reporting general health status per EORTC QLQ-CR29 in CRC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
• Patient reporting general health status per EORTC QLQ-BR23 in breast cancer patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC-QLQ-BR23 includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions use 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Scores average and transforme to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems.
• Patient reporting general health status per EORTC QLQ-LC13 in NSCLC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC QLQ-LC13 is a 13-item, disease-specific module which assesses quality of life across multiple scales, including dyspnea, cough and chest pain. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".
• Patient reporting general health status per EORTC QLQ-HN35 in HNSCC patients [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EORTC QLQ-HN35 is a 35-item, disease-specific module which assesses quality of life across multiple scales, including pain, swallowing, and senses. The questionnaire has 35 Likert type questions in total and the evaluation is made by giving the score of None: 1, A little: 2, Quite: 3, A lot: 4.
• Patient reporting general health status per EQ-5D-5L [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

Original Secondary Outcome Measures (submitted: November 6, 2020)

• Drug concentrations of REGN7075 in serum [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• Drug concentrations of cemiplimab [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• ORR [ Time Frame: Up to 5 years ]
  Dose escalation
• Progression free survival (PFS) [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• Duration of Response (DOR) [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• Disease control rate (DCR) [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• Complete response (CR) rate [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• Overall survival (OS) [ Time Frame: Up to 5 years ]
  Dose escalation and dose expansion
• Incidence of anti-drug antibodies (ADA) to REGN7075 [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose escalation and dose expansion
• Incidence of ADA to cemiplimab [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose escalation and dose expansion
• The incidence and severity of TEAEs [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose expansion
• The incidence and severity of AESIs [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose expansion
• The incidence and severity of SAEs [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose expansion
• The incidence and severity of grade ≥3 laboratory abnormalities [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
  Dose expansion

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: REGN7075 in Combination With Cemiplimab in Adult Participants With Advanced Solid Tumors
• Official Title: A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Brief Summary

The primary objective of the study is:

Dose Escalation:

• To assess the safety and tolerability of a REGN7075 monotherapy lead-in and REGN7075 in combination with cemiplimab in patients with advanced solid tumors

Dose Expansion:

• To assess the preliminary efficacy of REGN7075 in combination with cemiplimab within selected advanced solid tumor-specific cohorts, as measured by objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and/or composite response criteria

The secondary objectives of the study are:

Dose Escalation:

• To characterize the pharmacokinetics (PK) of REGN7075 alone and in combination with cemiplimab
• To assess the preliminary efficacy of REGN7075 in combination with cemiplimab, as measured by ORR, overall survival (OS), progression free survival (PFS), duration of response (DOR), complete response (CR) rate, and disease control rate (DCR) per RECIST 1.1 and/or composite response criteria
• To assess immunogenicity of REGN7075 and cemiplimab

Dose Expansion:

• To assess the preliminary efficacy of REGN7075 in combination with cemiplimab within selected advanced solid tumor-specific cohorts of patients as measured by OS, PFS, DOR, CR rate, and DCR per RECIST 1.1 and/or composite response criteria
• To assess the safety and tolerability of REGN7075 in combination with cemiplimab
• To characterize the PK of REGN7075 alone and in combination with cemiplimab
• To assess immunogenicity to REGN7075 and cemiplimab
• To assess the effect of REGN7075 on patient-reported outcomes, including health related quality of life (HRQoL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), EORTC QLQ-CR29 (among CRC patients only), EORTC-QLQ-BR23 (breast cancer patients only), EORTC QLQ-LC13 (among NSCLC patients only) and EORTC QLQ-HN35 (among HNSCC patients only) and EQ-5D-5L

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Advanced Solid Tumors

Intervention

• Drug: REGN7075
  Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
• Drug: cemiplimab
  administered concomitantly Q3W by IV infusion or SC injection
  Other Names:

  • REGN2810
  • Libtayo

Study Arms

• Experimental: Dose Escalation
  Variety of mixed advanced solid tumor types
  Interventions:

  • Drug: REGN7075
  • Drug: cemiplimab
• Experimental: Dose Expansion A
  Microsatellite-Stable Colorectal Cancer (MSS CRC)
  Interventions:

  • Drug: REGN7075
  • Drug: cemiplimab
• Experimental: Dose Expansion B
  Triple Negative Breast Cancer (TNBC)
  Interventions:

  • Drug: REGN7075
  • Drug: cemiplimab
• Experimental: Dose Expansion C
  Cutaneous Squamous Cell Carcinoma (CSCC)
  Interventions:

  • Drug: REGN7075
  • Drug: cemiplimab
• Experimental: Dose Expansion D
  Non-Small Cell Lung Cancer (NSCLC)
  Interventions:

  • Drug: REGN7075
  • Drug: cemiplimab
• Experimental: Dose Expansion E
  Head and Neck Squamous Cell Carcinoma (HNSCC)
  Interventions:

  • Drug: REGN7075
  • Drug: cemiplimab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 4, 2021): 402
• Original Estimated Enrollment (submitted: November 6, 2020): 312
• Estimated Study Completion Date: April 3, 2025
• Estimated Primary Completion Date: April 3, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

1. ≥18 years of age (≥20 years of age for patients enrolled in Japan)
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol
4. Expansion Cohorts only: Is anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) naïve, defined as never having previously been treated with a drug that targets the PD-1
5. Has at least 1 lesion that meets study criteria as defined in the protocol
6. Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy) from a tumor site that has not been previously irradiated
7. Has adequate organ and bone marrow function as defined in the protocol
8. In the judgement of the investigator, has a life expectancy of at least 3 months

Key Exclusion Criteria:

1. Is currently participating in another study of a therapeutic agent
2. Has participated in any study of an investigational agent or an investigational device within 4 weeks of the first administration of study drug as defined in the protocol
3. Has received treatment with an approved systemic therapy within 4 weeks of the first administration of study drug or has not yet recovered (ie, grade 1 or baseline) from any acute toxicities
4. Has received recent anti-epidermal growth factor receptor (EGFR) antibody therapy as defined in the protocol
5. Has received radiation therapy or major surgery within 14 days of the first administration of study drug or has not recovered (ie, grade 1 or baseline) from adverse events
6. Has received any previous systemic, non-immunomodulatory biologic therapy within 4 weeks of first administration of study drug.
7. Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug as defined in the protocol
8. Has second malignancy that is progressing or requires active treatment as defined in the protocol
9. Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks prior to the first dose of study drug as defined in the protocol
10. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments as defined in the protocol
11. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression
12. Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or uncontrolled seizures within 1 year prior to the first dose of study drug
13. Has any ongoing inflammatory skin disease as defined in the protocol NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Clinical Trials Administrator; 844-734-6643; clinicaltrials@regeneron.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04626635
• Other Study ID Numbers: R7075-ONC-2009; 2022-501234-37-00 ( Other Identifier: EU CTR-CTIS )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: Analytic Code
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• URL: https://vivli.org/

• Current Responsible Party: Regeneron Pharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: Regeneron Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trial Management; Regeneron Pharmaceuticals

• PRS Account: Regeneron Pharmaceuticals
• Verification Date: June 2022