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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Withdrawn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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT02924233

First Posted

September 28, 2016

Last Updated

August 25, 2017

Sponsor

Symphogen A/S

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

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

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

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