Description:
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.
Title
- Brief Title: Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
- Official Title: A Phase 1 Study of REGN4659 (Anti-CTLA-4 mAb) in Combination With Cemiplimab (Anti-PD-1 mAb) in the Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
R4659-ONC-1795
- NCT ID:
NCT03580694
Conditions
- Carcinoma, Non-Small-Cell Lung
Interventions
Drug | Synonyms | Arms |
---|
REGN4659 | | Combination Therapy |
Cemiplimab | REGN2810 | Cemiplimab Monotherapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Cemiplimab Monotherapy | Experimental | In a single dose escalation cohort, participants will receive cemiplimab alone. | |
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. | |
Eligibility Criteria
KEY Inclusion Criteria:
1. Patients with histologically or cytologically documented squamous or non-squamous
NSCLC with unresectable stage IIIB or stage IV disease
2. 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.
3. 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
4. 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
KEY Exclusion Criteria:
1. Expansion cohort(s) only: Patients who have never smoked, defined as smoking ≤100
cigarettes in a lifetime
2. 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
3. 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.
4. Radiation therapy within 2 weeks prior to enrollment and not recovered to baseline
from any AE due to radiation
5. Patients who received prior treatment with an anti-cytotoxic T-lymphocyte-associated
protein 4 (CTLA-4) antibody
6. Previous treatment with idelalisib (ZYDELIG®) at any time
Note: Other protocol defined inclusion/ exclusion criteria apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Rate of dose limiting toxicities (DLTs) during the dose escalation phase |
Time Frame: | Up to week 126 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | ORR based on RECIST 1.1 during the dose escalation phase |
Time Frame: | Up to week 126 |
Safety Issue: | |
Description: | |
Measure: | ORR based on immune-based therapy Response Evaluation Criteria (iRECIST) |
Time Frame: | Up to week 126 |
Safety Issue: | |
Description: | |
Measure: | Best overall response (BOR) |
Time Frame: | Up to week 126 |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR) |
Time Frame: | Up to week 126 |
Safety Issue: | |
Description: | |
Measure: | Disease control rate |
Time Frame: | Up to week 126 |
Safety Issue: | |
Description: | |
Measure: | Progression-free-survival (PFS) based on RECIST 1.1 |
Time Frame: | Up to week 126 |
Safety Issue: | |
Description: | |
Measure: | PFS based on iRECIST |
Time Frame: | Up to week 126 |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | Up to week 126 |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Regeneron Pharmaceuticals |
Trial Keywords
- Non-Small Cell Lung Cancer
- NSCLC
- Anti-PD-1
- Anti-CTLA-4
- Immunotherapy
Last Updated
March 13, 2020