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A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer

A Phase 1 Trial of CV301 in Combination With Anti- PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer

NCT02840994•Bavarian Nordic

View on ClinicalTrials.gov

Summary

The objective of the proposed clinical trial is to investigate the safety and tolerability of CV301 in combination with Anti-PD1-Therapy in subjects with non-small cell lung cancer (NSCLC). The clinical trial is designed to evaluate the possible enhanced antitumor activity of CV301 with Anti-PD1-Therapy. The rationale for combining CV301 with Anti-PD1-Therapy is based on the hypothesis that CV301 can induce specific immune response in the tumor, and that in combination, Anti-PD1-Therapy may augment the T cell-mediated immune response generated by CV301 by blocking the inhibitory signal of the PD-1. The trial will include a Phase 1 portion and a Phase 1b portion with 2 cohorts. The Phase 1 portion is a dose escalation part to assess the safety and tolerability of CV301 alone, prior to moving into the combination with Anti-PD1-Therapy (the Phase 1b component). The following Phase 1b portion of the trial aims to test the safety and tolerability of the combination treatment using a two cohort approach with cohort 1 receiving CV301 plus Nivolumab and cohort 2 receiving CV301 plus Pembrolizumab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects must have a metastatic or unresectable locally advanced malignant solid tumor, histologically confirmed by the Laboratory of Pathology, NCI. Efforts will be made, as much as possible, to enroll subjects with tumor types with known increased expression of CEA or MUC-1 (such as lung, breast, ovarian, prostate, colorectal, pancreatic, bladder, gastric, cervix, etc.).
•2. Subjects may have measurable or nonmeasurable but evaluable disease. Subjects with surgically resected or ablated metastatic disease at high risk of relapse are also eligible.
•Prior therapy: Subjects must have completed or had disease progression on at least one prior line of disease-appropriate therapy for locally advanced or metastatic disease, or not be candidates for therapy of proven efficacy for their disease.
•3. Subjects with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations.
•4. There should be a minimum of 4 weeks from any prior chemotherapy, immunotherapy and/or radiation, with the exception of hormonal therapy for prostate and breast cancers, HER2-directed therapy for HER2+ breast cancer (3+ IHC or FISH+), maintenance therapy for colorectal or pancreatic cancer, and erlotinib therapy in EGFR-mutated lung cancer under the condition that subjects are on these therapies for at least two months before start of trial treatment. There should be a minimum of 6 weeks from any prior antibody therapies (such as ipilimumab or Anti-PD1/PDL1) due to prolonged half-life.
•5. Subjects must have recovered (Grade 1 or baseline) from any clinically significant toxicity associated with prior therapy. Typically, this is 3-4 weeks for subjects who most recently received cytotoxic therapy, except for nitrosoureas and mitomycin C, for which 6 weeks is needed for recovery.
•6. Men or women, age ≥ 18 years.
•7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 or Karnofsky ≥ 70%, (see Section 19.1, Appendix I and Section 19.2, Appendix II).
•8. Subjects must have normal organ and marrow function as defined below
•a. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below): i. Female CrCl = \[(140 - age in years) x weight in kg x 0.85\] / \[72 x serum creatinine in mg/dL\] ii. Male CrCl = \[(140 - age in years) x weight in kg x 1.00\] / \[72 x serum creatinine in mg/dL\] b. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 x the ULN c. Total bilirubin ≤ 1.5 x ULN OR in subjects with Gilbert's syndrome, a total bilirubin ≤ 3.0 x ULN d. Hematological eligibility parameters (within 16 days of starting therapy): i. Platelet count ≥ 100,000/µL ii. Absolute neutrophil count (ANC) ≥ 1/ µL
+41 more criteria

Exclusion Criteria

•1. Subjects with EGFR mutations, ALK or ROS-1 translocations candidates to targeted therapy.
•2. Squamous histology of NSCLC.
•3. Other concurrent investigational agents (subjects are eligible to enroll 4 weeks after completion of prior investigational agent).
•4. More than 1 prior chemotherapy regimen for locally advanced or metastatic NSCLC with the exception of the Phase 1 portion, in which multiple therapies are allowed in all tumor types. Any prior chemotherapy regimen different from pemetrexed-carboplatinum in combination with Pembrolizumab as first-line chemotherapy for candidates to Pembrolizumab maintenance of first line (Phase 1b).
•14. Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
•15. Pregnant or breastfeeding women.
•16. Clinically significant cardiomyopathy, coronary disease, heart failure New York Heart Association class III or IV, or cerebrovascular accident within 1 year.
•17. Uncontrolled intercurrent illness, which would interfere with the ability of the subject to carry out the treatment program.
•18. Any other condition, which would, in the opinion of the Principal Investigator or Medical Monitor, indicate the subject is a poor candidate for treatment with CV301 or would jeopardize the subject or the integrity of the data obtained.
•19. Medical or psychological impediment to compliance with protocol.

Locations (7)

H. Lee Moffitt Cancer Center & Research Institute, Inc.

Tampa, Florida, United States

Investigative Clinical Research of Indiana

Indianapolis, Indiana, United States

Metairie Oncologist, LLC

Metairie, Louisiana, United States

NCI

Bethesda, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Novant Health Oncology Specialists

Winston-Salem, North Carolina, United States

Millennium Oncology

Houston, Texas, United States

Key Dates

Start Date

December 1, 2016

Primary Completion Date

January 1, 2020

Completion Date

January 1, 2020

Last Updated

February 27, 2020

Enrollment

ACTUAL participants

Conditions

Non-small Cell Lung Cancer (NSCLC)

Interventions

CV301

BIOLOGICAL

Pembrolizumab

BIOLOGICAL

Nivolumab

BIOLOGICAL

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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RECRUITINGPHASE3

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

NCT05920356

Non-Small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer

Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer

Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs