Status:
ACTIVE_NOT_RECRUITING
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Lead Sponsor:
Candel Therapeutics, Inc.
Collaborating Sponsors:
NYU Langone Health
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to evaluate the effects of adding CAN-2409 + prodrug for stage III/IV NSCLC patients who are on standard of care first line immune checkpoint inhibitor (ICI) trea...
Detailed Description
This clinical trial evaluates the addition of CAN-2409 plus prodrug for stage III/IV NSCLC patients who are on standard of care first line ICI (anti-PD-1/PD-L1) but with evidence of suboptimal respons...
Eligibility Criteria
Inclusion
- Patients with Stage III/IV NSCLC on first line treatment with anti-PD-1/PD-L1 (ICI) +/- chemotherapy for their current stage of disease and fits into one of the following cohorts as determined by investigator, preferably as per RECIST 1.1: Cohort 1) have persistent but stable disease at least 18 weeks after starting ICI treatment, or Cohort 2) have radiographic progressive disease at least 18 weeks after starting ICI treatment
- RECIST evaluable disease including a lesion that is amenable to injection
- Able and willing to undergo a pre-treatment and on-treatment biopsies, if feasible
- ECOG Performance status of 0 or 1
- 18 years of age or older
- Granulocyte count (ANC) ≥ 1,000/mm3
- Hemoglobin ≥ 8 g/dl (patients may be transfused to meet this criterion)
- Platelets ≥ 75,000/mm3
- Total bilirubin ≤ 1.5 x upper limit of normal, except for patients with known Gilbert disease who must have total bilirubin ≤ 3 x upper limit of normal
- SGOT (AST) ≤ 5x upper limit of normal and if elevated, not clinically significant such that ICI can continue
- INR no more than 0.2 above upper limit of normal and aPTT not \>1.2 x upper limit of normal, and value is acceptable for patient to undergo injection procedure. If on anti-coagulation, it must be clinically acceptable to hold anti-coagulation for the injection procedures per investigator discretion
- Serum creatinine \< 2mg/dl and calculated creatinine clearance \> 30ml/min
- Clinically stable and able to continue ICI for at least the 12-week treatment period
- Within 6 months of enrollment, no change of ICI therapy or prior interruptions of more than 4 weeks of current ICI
- Patients should not have received focal therapy (e.g., radiotherapy) at more than three different sites of disease within 12-months prior to enrollment
- Patients must give study specific informed consent prior to enrollment and any study specific procedures
Exclusion
- Patients with a history of severe immune related adverse events related to ICI
- Patients who require ongoing therapy with disease-modifying antirheumatic drugs (DMARDs), immunomodulators or systemic immunosuppressive drugs including systemic corticosteroids (\>10 mg prednisone per day or equivalent) - premedication for ICI or chemotherapy is allowed
- Patients with a history of active autoimmune disease requiring treatment in the past 2 years
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active hepatitis, or psychiatric illness/social situations that would limit compliance with study requirements
- Women who are pregnant, lactating or intend to become pregnant during the study
- Patients who are known to be HIV positive
- Patients with a history of hypersensitivity or allergic reactions to valacyclovir or acyclovir
- Patients with significant heart disease (New York Heart Association Functional Classification III or IV)
- Patients with continuous oxygen dependence \>2L/min at rest
- Tumor impinging on a neurovascular structure such that inflammation in the site may put patient at risk of compromise as determined by the investigator
- Patients with uncontrolled brain metastases as per investigator
- Patients with liver metastases involving more than half of the liver
- Patients with known EGFR mutation, ALK fusion, or ROS1 fusion positive NSCLC, or that are receiving tyrosine kinase inhibitor (TKI) agents/ALK/ROS1 inhibitors
- Patients with known interstitial lung diseases (ILDs) requiring active therapy (Radiographic fibrosis not requiring therapy is allowed)
- Patients receiving vascular endothelial growth factor (VEGF) inhibitors (including bevacizumab, ramucirumab) within the past 2 months or five half-lives, whichever is longer
- Patients must have no concurrent malignancy requiring treatment (except squamous or basal cell skin cancers)
- Patients without contrast enhanced imaging at baseline or those with contraindication to the use of contrast.
- Patients who are pregnant, breastfeeding, or plan to become pregnant.
Key Trial Info
Start Date :
October 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04495153
Start Date
October 13 2020
End Date
December 1 2026
Last Update
August 22 2025
Active Locations (14)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
UConn Health
Farmington, Connecticut, United States, 06030
3
Yale University, Yale Cancer Center
New Haven, Connecticut, United States, 06510
4
University of Chicago
Chicago, Illinois, United States, 60637