Ziv-aflibercept + Pembrolizumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new ways to treat advanced solid tumors that may have spread. Researchers are testing two drugs, ziv-aflibercept (an anti-cancer medication) and pembrolizumab (an immunotherapy drug), to assess their effectiveness in shrinking tumors and enhancing the immune system's ability to fight cancer. The trial seeks participants with specific types of cancer, including melanoma, renal cell carcinoma, ovarian cancer, colorectal cancer, or sarcoma, who have experienced resistance to certain treatments and have measurable disease. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of ziv-aflibercept and pembrolizumab is generally well-tolerated. Studies with patients who have advanced solid tumors indicate that this combination has an acceptable safety profile, meaning most people do not experience severe side effects.
Common side effects include fatigue, nausea, and changes in blood pressure, but these effects are often manageable. Both ziv-aflibercept and pembrolizumab are already used in other treatments, and their individual safety is well understood, adding confidence to their combined use.
In summary, existing research suggests that this treatment combination is safe for humans, with manageable side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of ziv-aflibercept and pembrolizumab for cancer treatment because it offers a unique approach compared to current options. Most cancer treatments focus on either inhibiting cancer growth or boosting the immune system. Ziv-aflibercept blocks blood vessel growth that tumors need to thrive, while pembrolizumab enhances the immune system's ability to detect and destroy cancer cells. This dual action not only targets the cancer directly but also empowers the body’s natural defenses, potentially leading to more effective and longer-lasting results.
What evidence suggests that this trial's treatments could be effective for advanced solid tumors?
Research has shown that combining ziv-aflibercept and pembrolizumab may help treat advanced solid tumors. Ziv-aflibercept stops the blood supply to tumors, potentially shrinking them. Pembrolizumab boosts the immune system to attack cancer cells. Studies have found that this combination can effectively fight tumors. Participants in this trial will receive both ziv-aflibercept and pembrolizumab. Patients in earlier studies experienced manageable side effects and some positive results, suggesting this treatment could be effective.12346
Who Is on the Research Team?
Frank S Hodi
Principal Investigator
Dana-Farber - Harvard Cancer Center LAO
Are You a Good Fit for This Trial?
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 for a Trial Participant
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.
What Are the Treatments Tested in This Trial?
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