Volrustomig for Squamous Cell Carcinoma
(eVOLVE-02 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called volrustomig, a potential new drug, to evaluate its effectiveness and safety for individuals with advanced or metastatic solid tumors. Some participants will receive volrustomig alone, while others will receive it in combination with common cancer drugs. The trial targets individuals with specific types of head and neck or cervical cancer who have not responded to previous treatments. Participants should have tumors that cannot be cured with local treatments and must have experienced cancer progression despite standard care. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications to join the trial?
The trial protocol does not specify if you must stop taking your current medications, but you cannot use immunosuppressive medications within 14 days before starting the study. Also, you cannot have received any anti-cancer therapy within 28 days before the first dose of the study intervention.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that volrustomig is being tested both on its own and with other cancer drugs. Earlier studies found that most people tolerate it well when used alone. Some experience mild side effects, but serious issues are rare.
Volrustomig has also been tested in combination with common cancer drugs like carboplatin and paclitaxel, or 5-FU and platinum, in several studies. Most patients manage these treatments well, though some may experience typical side effects like nausea or fatigue.
Overall, while no treatment is without risks, the safety data so far suggests that volrustomig, whether used alone or with other drugs, is safe for many patients. This ongoing research enhances understanding of its safety.12345Why are researchers excited about this trial's treatments?
Volrustomig is unique because it offers a new approach to treating squamous cell carcinoma by acting both as a monotherapy and in combination with established chemotherapy agents like carboplatin and paclitaxel. Unlike the standard of care, which typically involves surgery, radiation, and traditional chemotherapy, Volrustomig targets specific pathways in cancer cells, potentially leading to more effective and targeted treatment outcomes. Researchers are excited about Volrustomig because it could reduce side effects and improve patient quality of life by sparing healthy cells while directly attacking cancerous ones.
What evidence suggests that this trial's treatments could be effective for squamous cell carcinoma?
Research has shown that volrustomig, one of the treatments in this trial, may help treat advanced squamous cell carcinoma. Early studies found that using volrustomig alone helped control the disease in most patients, slowing or stopping cancer growth. In this trial, some participants will receive volrustomig monotherapy, while others will receive volrustomig combined with chemotherapy drugs like carboplatin and paclitaxel. The combination treatment has also produced good results, suggesting that volrustomig could effectively manage squamous cell carcinoma and offer hope for better treatment options.12345
Are You a Good Fit for This Trial?
Adults over 18 with advanced/metastatic solid tumors, specifically squamous cell carcinoma or cervical cancer, can join. They must have a life expectancy of at least 12 weeks, be able to provide a tumor sample for testing, and have an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory). Participants need adequate organ function and weigh more than 35 kg.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Volrustomig monotherapy or in combination with chemotherapy is administered to participants with advanced/metastatic solid tumors
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Volrustomig
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology