Ziv-aflibercept + Pembrolizumab for Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you have had chemotherapy, targeted therapy, or radiotherapy within 4 weeks before the study, or if you are on certain immunosuppressive therapies. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Ziv-aflibercept and Pembrolizumab for cancer?
Is the combination of Ziv-aflibercept and Pembrolizumab safe for humans?
Pembrolizumab (also known as KEYTRUDA) has been shown to be generally safe in humans, with common side effects including tiredness, rash, itching, and diarrhea. Ziv-aflibercept (also known as Zaltrap) has been used safely in combination with other treatments for cancer, but it can increase some chemotherapy-related side effects. Both drugs have been tested in various conditions, showing a favorable safety profile.56789
What makes the drug combination of Ziv-aflibercept and Pembrolizumab unique for cancer treatment?
This drug combination is unique because it combines Ziv-aflibercept, which inhibits blood vessel growth in tumors, with Pembrolizumab, an immune checkpoint inhibitor that helps the immune system attack cancer cells. This dual approach targets both the tumor's blood supply and enhances the body's immune response against cancer.1261011
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of ziv-aflibercept when given together with pembrolizumab in treating patients with solid tumors that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Ziv-afibercept works by decreasing blood and nutrient supply to the tumor, which may result in shrinking the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ziv-aflibercept together with pembrolizumab may be a better treatment for patients with advanced solid tumors.
Research Team
Frank S Hodi
Principal Investigator
Dana-Farber - Harvard Cancer Center LAO
Eligibility Criteria
Adults with advanced solid tumors, specifically melanoma, renal cancer, ovarian cancer or colorectal cancer that's spread and is resistant to certain treatments. Participants must have adequate organ function, no more than two prior therapies for metastatic disease, and not be pregnant or breastfeeding. They should agree to use contraception and not have a history of severe autoimmune diseases or other conditions that could interfere with the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab and ziv-aflibercept intravenously. Cycles repeat every 2 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, including CT scans, MRIs, blood sample collection, and tumor biopsy.
Treatment Details
Interventions
- Pembrolizumab
- Ziv-Aflibercept
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?
National Cancer Institute (NCI)
Lead Sponsor