Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer
Primary Purpose
Squamous Non-Small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Sym004
Nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Non-Small Cell Lung Cancer focused on measuring Squamous, Non-Small Cell Lung Cancer, NSCLC
Eligibility Criteria
Main Inclusion Criteria:
- Signed and dated written informed consent
- Male or female ≥18 years of age at the time of informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy >3 months assessed during Screening
- Histologically or cytologically confirmed, locally advanced or metastatic squamous NSCLC
Main Exclusion Criteria:
- Any antineoplastic agent (standard or investigational) within 2 weeks prior to starting trial treatment
- Radiosurgery or radiotherapy for target lesions within 2 weeks prior to starting trial treatment
- Prophylactic use of hematopoietic growth factors within 1 week prior to starting trial treatment
- Active Central Nervous System (CNS) metastases or carcinomatous meningitis
- Women who are pregnant
- Women who are breastfeeding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Sym004 + nivolumab
Sym004 (RP2D) + nivolumab
Nivolumab
Arm Description
Phase 1b, dose-escalation: Dose Level 1: Sym004 + nivolumab (Q2W) Dose Level 2: Sym004 + nivolumab (Q2W) Dose Level -1: Sym004 + nivolumab, if needed
Phase 2b, dose-expansion: Receiving Sym004 in the RP2D in combination with nivolumab (Q2W)
Phase 2b, dose-expansion: Receiving nivolumab monotherapy (Q2W)
Outcomes
Primary Outcome Measures
Phase 1b: Determination of the Dose-Limiting Toxicities (DLT) and the MTD and/or RP2D of escalating doses of Sym004 in combination with a standard dose of nivolumab
Phase 2b: Evaluation of the antitumor effects of the RP2D of Sym004 when administered in combination with a standard dose of nivolumab as measured by Response Rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02924233
Brief Title
Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer
Official Title
An Open-label, Randomized, Multicenter, Phase 1b/2b Trial Investigating the Safety and Preliminary Antitumor Effects of Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Symphogen made a business decision to no longer perform the clinical study
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Symphogen A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase 1b/2b study investigating the safety and preliminary antitumor effects of Sym004 in combination with nivolumab versus nivolumab monotherapy when administered every second week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Non-Small Cell Lung Cancer
Keywords
Squamous, Non-Small Cell Lung Cancer, NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sym004 + nivolumab
Arm Type
Experimental
Arm Description
Phase 1b, dose-escalation:
Dose Level 1: Sym004 + nivolumab (Q2W)
Dose Level 2: Sym004 + nivolumab (Q2W)
Dose Level -1: Sym004 + nivolumab, if needed
Arm Title
Sym004 (RP2D) + nivolumab
Arm Type
Experimental
Arm Description
Phase 2b, dose-expansion:
Receiving Sym004 in the RP2D in combination with nivolumab (Q2W)
Arm Title
Nivolumab
Arm Type
Active Comparator
Arm Description
Phase 2b, dose-expansion:
Receiving nivolumab monotherapy (Q2W)
Intervention Type
Drug
Intervention Name(s)
Sym004
Intervention Description
Sym004 is a 1:1 mixture of two monoclonal antibodies (mAbs) which bind to two non-overlapping epitopes of the Epidermal Growth Factor Receptor (EGFR).
Sym004 will be administered at different dose-levels via infusion Q2W
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Nivolumab is a humanized immunoglobulin G4 (IgG4) anti-PD-1 monoclonal antibody. Nivolumab will be administered via 60-minute infusion Q2W
Primary Outcome Measure Information:
Title
Phase 1b: Determination of the Dose-Limiting Toxicities (DLT) and the MTD and/or RP2D of escalating doses of Sym004 in combination with a standard dose of nivolumab
Time Frame
1 year
Title
Phase 2b: Evaluation of the antitumor effects of the RP2D of Sym004 when administered in combination with a standard dose of nivolumab as measured by Response Rate
Time Frame
1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Signed and dated written informed consent
Male or female ≥18 years of age at the time of informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy >3 months assessed during Screening
Histologically or cytologically confirmed, locally advanced or metastatic squamous NSCLC
Main Exclusion Criteria:
Any antineoplastic agent (standard or investigational) within 2 weeks prior to starting trial treatment
Radiosurgery or radiotherapy for target lesions within 2 weeks prior to starting trial treatment
Prophylactic use of hematopoietic growth factors within 1 week prior to starting trial treatment
Active Central Nervous System (CNS) metastases or carcinomatous meningitis
Women who are pregnant
Women who are breastfeeding
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer
We'll reach out to this number within 24 hrs