Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung

NCT02466568 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: MCC-181471504-1392
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to find out what effects (good and bad) a tumor vaccine (GM.CD40L) used in combination with Nivolumab will have on participants and their cancer. Another purpose of the study is to find out the maximum tolerated dose of nivolumab in combination with GM.CD40L vaccine. Investigators also want to find out if the combination of GM.CD40L and nivolumab can boost the immune system of participants like you, and how their immune system reacts, both before and after the treatment.

Conditions

Lung Cancer; Adenocarcinoma of the Lung

Keywords

advanced; metastatic; lung disease; adenocarcinoma; non-small cell lung cancer (NSCLC)

Outcome Measures

Primary Outcomes (2)

• Phase I: Recommended Phase II Dose

  The recommended Phase II dose will be defined as the highest dose level of GMCD40L vaccine in combination with nivolumab that induced dose limiting toxicity (DLT) in fewer than 33% of patients.

  Up to 2 months

• Phase II: Objective Response Rate (ORR)

  Objective tumor response per treatment arm. ORR: Complete Response (CR) = disappearance of all target lesions + Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions.

  Up to 2 years

Secondary Outcomes (2)

• Phase II: Overall Survival (OS)

  Up to 2 years

• Phase II: Progression-free Survival (PFS)

  Up to 2 years

Study Arms (2)

Phase I and Phase II Treatment Arm

EXPERIMENTAL

Participants will receive nivolumab and GM.CD40L. Treatment will be administered on an outpatient basis. The nivolumab will be given first followed by the GM.CD40L vaccine for those enrolled on this arm.

Drug: Nivolumab; Biological: GM.CD40L Vaccine

Phase II Control Arm

ACTIVE COMPARATOR

Nivolumab treatment without GM.CD40L. Nivolumab will be given every 2 weeks at a dose of 3mg/kg.

Drug: Nivolumab

Interventions

Nivolumab DRUG

Participants will receive treatment with nivolumab as a 60-minute +/-5 minutes intravenous (IV) infusion on Day 1 and 15 of each 28-day cycle.

Also known as: Opdivo, Anti-PD-1

Phase I and Phase II Treatment Arm; Phase II Control Arm

GM.CD40L Vaccine BIOLOGICAL

GM.CD40L will be injected intradermally every 2 weeks for 4 injections, then every month for 4 injections, then every 3 months until the patient is off treatment.

Also known as: Immunotherapy, Cell Vaccine

Phase I and Phase II Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Histologic or cytologic diagnosis of advanced/metastatic adenocarcinoma of the lung
• Eastern Cooperative Oncology Group (ECOG) performance status of 0/1
• Chemotherapy naïve or have completed adjuvant chemotherapy for non-small cell lung cancer (NSCLC) \>6 months prior
• Adequate bone marrow, renal and hepatic function
• Must have measurable metastatic disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
• Mandatory archival tissue or willingness to undergo a fresh biopsy
• Life expectancy of greater than 6 months

You may not qualify if:

• Symptomatic brain metastasis or uncontrolled central nervous system (CNS) metastasis
• Pregnancy or breast feeding
• Serious uncontrolled medical disorder or active infection that would impair the participant's ability to receive study treatment
• Prior use of a PD1 or PDL1 inhibitor
• Concurrent use of other anticancer approved or investigational agents is not allowed
• Autoimmune disorders
• Prior malignancy in past 2 years
• Systemic steroids at doses greater than 10 mg/day of prednisone or the equivalent
• Any other pre-existing immunodeficiency condition (including known HIV infection)

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung; Neoplasm Metastasis; Lung Diseases; Adenocarcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; spartalizumab; Immunotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Jhanelle Gray, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 9, 2015
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: September 9, 2019

Record last verified: 2019-09