Combination Immunotherapy + VSV-IFNβ-NIS for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of a virus-based therapy and an immune-boosting drug for patients with hard-to-treat cancers. The treatment works by making cancer cells more visible to the immune system and keeping the immune system active against them.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, it mentions that prior therapies like chemotherapy or immunotherapy should not have been received within a certain timeframe before starting the study treatment. It's best to discuss your specific medications with the trial team.
Is the combination immunotherapy with Pembrolizumab generally safe for humans?
What makes the combination immunotherapy with Pembrolizumab and VSV-IFNβ-NIS unique for treating solid tumors?
This treatment is unique because it combines Pembrolizumab, a PD-1 inhibitor that helps the immune system attack cancer cells, with VSV-IFNβ-NIS, a virus engineered to selectively infect and kill cancer cells while sparing normal cells. This dual approach aims to enhance the immune response against tumors more effectively than using Pembrolizumab alone.25678
What data supports the effectiveness of the drug pembrolizumab in treating solid tumors?
Who Is on the Research Team?
Patrick McGarrah, MD
Principal Investigator
Mayo Clinic
Alex Adjei, MD, PhD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) or neuroendocrine carcinoma (NEC) that worsened on PD-1/PD-L1 inhibitor therapy. They should have a life expectancy over 3 months, no active brain cancer involvement, good organ function, and be willing to provide tissue samples. Pregnant women, those with certain autoimmune diseases or unresolved treatment toxicities, and individuals with other serious health risks are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in/Dose Escalation
Safety run-in to identify the optimal dose of VSV-IFNβ-NIS in combination with pembrolizumab, following a 3+3 design
Treatment
Participants receive VSV-IFNβ-NIS in combination with checkpoint inhibitors, with efficacy evaluations every 9 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- VSV-IFNβ-NIS
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vyriad, Inc.
Lead Sponsor
Mayo Clinic
Collaborator