EphB4-HSA + Pembrolizumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two treatments: recombinant EphB4-HSA fusion protein (a new potential drug) and pembrolizumab (an immunotherapy drug). The aim is to determine if they can more effectively treat non-small cell lung cancer and head and neck cancer that have spread or returned. The trial seeks participants whose cancer has progressed after specific chemotherapy treatments or who have opted out of certain initial treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in cancer treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or immunosuppressive therapy, you must stop these at least 7 days before starting the trial treatment. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of recombinant EphB4-HSA fusion protein and pembrolizumab is generally safe. Most patients have tolerated this combination well. Studies found that side effects were usually manageable and did not cause serious problems for most participants.
The FDA has already approved pembrolizumab for other uses, indicating its general safety when used correctly. Adding recombinant EphB4-HSA fusion protein to pembrolizumab did not significantly increase side effects compared to those typically expected from pembrolizumab alone.
In summary, while every treatment can have side effects, research has found that this combination is safe, with most side effects being mild to moderate.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of pembrolizumab and the recombinant EphB4-HSA fusion protein because it brings a new approach to treating head and neck cancer and non-small cell lung cancer. Pembrolizumab is a well-known immunotherapy that helps the immune system recognize and attack cancer cells. The addition of EphB4-HSA introduces a novel mechanism by targeting the EphB4 protein, which is involved in cancer growth and blood vessel formation. This dual approach has the potential to enhance the effectiveness of pembrolizumab, offering hope for better outcomes compared to existing treatments like chemotherapy and radiation.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer and head and neck squamous cell cancer?
This trial will evaluate the combination of recombinant EphB4-HSA with pembrolizumab for treating certain cancers. Studies have shown that this combination might help by inhibiting enzymes necessary for cancer cell growth and enhancing the body's immune response to tumors. Pembrolizumab has already succeeded in treating several cancers, such as non-small cell lung cancer. Early results suggest that this combination could be effective for patients with specific characteristics, such as being HPV-negative and having the EphrinB2 marker. This approach could offer a new treatment option for non-small cell lung cancer and recurrent or metastatic head and neck squamous cell cancer.13567
Who Is on the Research Team?
Jorge J. Nieva
Principal Investigator
University of Southern California
Are You a Good Fit for This Trial?
This trial is for adults with certain advanced cancers, including non-small cell lung cancer and head and neck squamous cell carcinoma that have worsened despite treatment. Participants must have specific blood levels within normal ranges, be willing to provide tissue samples, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and cannot have had certain treatments recently or suffer from severe allergies or immune conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab IV on day 1 and recombinant EphB4-HSA fusion protein IV on days 1, 8, and 15, with courses repeating every 3 weeks for up to 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Recombinant EphB4-HSA Fusion Protein
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?
University of Southern California
Lead Sponsor
National Cancer Institute (NCI)
Collaborator