Ramucirumab + Pembrolizumab for Head and Neck Cancer (Rambro2 Trial)
Trial Summary
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids, intense immunosuppressive therapy, or chronic antiplatelet therapy, you may need to adjust or stop these before starting the trial.
Research shows that Pembrolizumab, one of the drugs in the combination, has been effective in treating head and neck cancer, especially in patients with high levels of PD-L1, a protein that can affect the immune system's ability to fight cancer. It has shown good tumor response and manageable side effects in several studies.
12345Pembrolizumab has been studied for head and neck cancer, showing some serious side effects like pneumonia, breathing problems, confusion, and immune system-related issues like inflammation of the lungs, liver, and thyroid problems. The safety of Ramucirumab in combination with Pembrolizumab specifically hasn't been detailed, but Pembrolizumab alone has a manageable safety profile in the context of head and neck cancer.
36789The combination of Ramucirumab and Pembrolizumab is unique because it pairs an immune checkpoint inhibitor (Pembrolizumab) that helps the immune system attack cancer cells with another drug (Ramucirumab) that targets blood vessels feeding the tumor, potentially enhancing the overall anti-cancer effect.
1261011Eligibility Criteria
Adults with PD-L1 positive head and neck squamous-cell carcinoma, who haven't had systemic therapy for recurrent/metastatic cancer. They must have measurable disease, be in good physical condition (ECOG 0-1), have normal organ/blood function, agree to use contraception, and not be pregnant or breastfeeding. Excluded are those with negative PD-L1 status, recent surgeries or significant bleeding events, other cancers within a year (except certain skin cancers), serious illnesses or uncontrolled hypertension.Inclusion Criteria
Exclusion Criteria
Participant Groups
- 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