Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT03580694 | Terminated Phase 1 FDA Drug

• 1 other identifier: R4659-ONC-1795
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 6

Brief Summary

The objective of this trial is to study REGN4659 and cemiplimab in treatment-experienced, non-small cell lung cancer (NSCLC) patients. There are 2 phases of this study: a dose escalation phase and a dose expansion phase.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-Small Cell Lung Cancer; NSCLC; Anti-PD-1; Anti-CTLA-4; Immunotherapy

Outcome Measures

Primary Outcomes (8)

• Rate of dose limiting toxicities (DLTs) during the dose escalation phase

  Up to week 126

• Rate of treatment emergent adverse events (TEAEs)

  Up to week 126

• Rate of immune-related adverse events (irAEs)

  Up to week 126

• Rate of serious adverse events (SAEs)

  Up to week 126

• Rate of deaths

  Up to week 126

• Laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE])

  Up to week 126

• Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during the dose expansion phase

  Up to week 126

• REGN4659 and cemiplimab concentrations in serum over time

  Up to week 126

Secondary Outcomes (8)

• ORR based on RECIST 1.1 during the dose escalation phase

  Up to week 126

• ORR based on immune-based therapy Response Evaluation Criteria (iRECIST)

  Up to week 126

• Best overall response (BOR)

  Up to week 126

• Duration of response (DOR)

  Up to week 126

• Disease control rate

  Up to week 126

Study Arms (2)

Cemiplimab Monotherapy

EXPERIMENTAL

In a single dose escalation cohort, participants will receive cemiplimab alone.

Drug: Cemiplimab

Combination Therapy

EXPERIMENTAL

Dose Escalation cohorts: In 3 dose escalation cohorts, participants will receive a lead-in dose of REGN4659 followed by REGN4659 and cemiplimab in combination. In 4 dose escalation cohorts, participants will receive REGN4659 with cemiplimab in combination. Dose Expansion cohorts: In dose expansion cohorts, participants will receive combination regimens of REGN4659 and cemiplimab.

Drug: REGN4659; Drug: Cemiplimab

Interventions

REGN4659 DRUG

REGN4659 will be administered by intravenous (IV) infusion.

Combination Therapy

Cemiplimab DRUG

Cemiplimab will be administered by intravenous (IV) infusion.

Also known as: REGN2810

Cemiplimab Monotherapy; Combination Therapy

Eligibility Criteria

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

You may qualify if:

• Patients with histologically or cytologically documented squamous or non-squamous NSCLC with unresectable stage IIIB or stage IV disease
• Combination dose escalation cohorts: Treatment-experienced patients who have received no more than 3 lines of systemic therapy including no more than 2 lines of cytotoxic chemotherapy, and for whom no available therapy has a high probability to convey clinical benefit.
• Dose escalation cohort C: Anti-PD-1/PD-L1 naïve patients who have received 1 to 2 prior lines of cytotoxic chemotherapy including a platinum doublet-containing regimen
• Expansion cohort(s): Anti-PD-1/PD-L1 experienced patients who have progressed while receiving therapy or within 6 months of stopping therapy for stage III or IV disease. Patients must not have permanently discontinued anti-PD-1/PD-L1 therapy due to treatment related AE. Patients must have received one line of anti-PD--1/PD-L1 immunotherapy. Patients may also have received one line of chemotherapy

You may not qualify if:

• Expansion cohort(s) only: Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
• Active or untreated brain metastases or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. Patients must be off (immunosuppressive doses of) corticosteroid therapy
• Expansion cohort(s) only: Patients with tumors tested positive for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) gene mutations or ROS1 fusions.
• Radiation therapy within 2 weeks prior to enrollment and not recovered to baseline from any AE due to radiation
• Patients who received prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody
• Previous treatment with idelalisib (ZYDELIG®) at any time

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (6)

Regeneron Investigational Site

Chicago, Illinois, 60637, United States

Location

Regeneron Investigational Site

Grand Rapids, Michigan, 49546, United States

Location

Regeneron Investigational Site

Charlotte, North Carolina, 28204, United States

Location

Regeneron Investigational Site

Oklahoma City, Oklahoma, 73104, United States

Location

Regeneron Investigational Site

Nashville, Tennessee, 37203, United States

Location

Regeneron Investigational Site

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 9, 2018
• Study Start: June 27, 2018
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

US (6)