Immunotherapy + Chemoradiation for Cancer
(CLOVER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of combining immunotherapy drugs, such as durvalumab and tremelimumab, with chemoradiation for individuals with advanced solid tumors. It specifically examines treatments for certain cancers, including small-cell lung cancer (SCLC), head and neck cancer (HNSCC), and non-small-cell lung cancer (NSCLC). Participants may qualify if they have been diagnosed with any of these cancers in advanced stages and have not received prior immune-based treatments. The trial aims to determine how well these treatments work together and whether patients can tolerate them safely. As a Phase 1 trial, the research focuses on understanding how the treatment functions in people, offering participants the opportunity to be among the first to receive this novel combination therapy.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that durvalumab, when combined with radiation and other drugs, is generally well-tolerated by people with head and neck cancer. Studies have found that combining durvalumab and cisplatin with radiation did not lead to unexpected side effects, indicating relative safety for most patients.
For non-small-cell lung cancer (NSCLC), researchers have extensively studied durvalumab combined with cisplatin and etoposide. The data show that common side effects include tiredness and nausea, but these are usually manageable. Using durvalumab with carboplatin and paclitaxel in NSCLC also resulted in similar manageable side effects.
Another combination, pemetrexed with carboplatin or cisplatin and radiation, has been found to be tolerable. Most side effects, like low blood counts and tiredness, were not severe.
In summary, these treatments have demonstrated a good safety profile in previous studies. However, discussing potential risks with a healthcare provider remains important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they combine immunotherapy with chemoradiation to attack cancer in multiple ways. Unlike standard treatments that primarily rely on chemotherapy and radiation, these investigational treatments use drugs like Durvalumab and Tremelimumab, which are immune checkpoint inhibitors that help the immune system recognize and destroy cancer cells more effectively. Additionally, the option to switch from cisplatin to carboplatin offers flexibility for patients who may not tolerate certain chemotherapy drugs well. This multi-faceted approach aims to increase effectiveness and minimize side effects compared to traditional therapies.
What evidence suggests that this trial's treatments could be effective for advanced solid tumors?
Research has shown that using durvalumab with cisplatin and radiation may help treat head and neck cancer. The CLOVER study found this combination safe and effective against tumors. One arm of this trial will test durvalumab with cisplatin and radiation for patients with locally advanced squamous cell carcinoma of the head and neck (HNSCC).
For lung cancer, the PACIFIC trial found that durvalumab helped patients live longer when used after chemotherapy and radiation. Different arms of this trial will explore combinations of durvalumab with other drugs like cisplatin and etoposide, or carboplatin and paclitaxel, for advanced non-small-cell lung cancer (NSCLC). Additionally, another arm will investigate the use of carboplatin with pemetrexed or cisplatin with pemetrexed for NSCLC. These studies suggest that these treatment combinations could effectively target advanced cancers.678910Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors, including various types of lung and oral cancers. Participants must have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory, weigh over 30 kg, have at least one measurable lesion not previously treated with radiation, and no prior immune therapy. Exclusions include multiple primary malignancies, brain metastases, autoimmune disorders, certain specific cancer exclusions per cohort (e.g., unresectable head and neck cancers), paraneoplastic syndromes of autoimmune nature, mixed histology lung cancers, active infections like TB or HIV.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose-limiting toxicity (DLT) assessment
Initial phase to assess the safety and tolerability of the treatment regimen
Expansion
Participants receive the study treatment to further evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Durvalumab
- Etoposide
- External beam radiation
- Paclitaxel
- Pemetrexed
- Tremelimumab
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
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