Opdivo (nivolumab) is an immunotherapy, a class of drugs representing a significant advancement in cancer treatment. Its development and application have been thoroughly evaluated through clinical trials, which are structured research studies investigating new medications.
Understanding Clinical Trials for New Treatments
Clinical trials evaluate the safety and effectiveness of new medical treatments like Opdivo. These trials are organized into distinct phases, each with specific objectives.
Phase 1 trials focus on drug safety, involving a small group of patients to determine the safest dosage and identify common side effects. Phase 2 trials assess the drug’s effectiveness in a larger patient group, while continuing to monitor safety.
Phase 3 compares the new treatment against existing standard therapies or a placebo in a large patient population, confirming efficacy and long-term safety. Patient participation is voluntary and regulated by ethical guidelines to protect participants.
Opdivo’s Role in Immunotherapy
Opdivo (nivolumab) is an immunotherapy and a PD-1 checkpoint inhibitor. PD-1 is a protein on immune cells, like T-cells, which fight disease.
Cancer cells can use the PD-1 pathway to evade the immune system by expressing PD-L1, which binds to PD-1 on T-cells, effectively deactivating them. Opdivo blocks the PD-1 protein, preventing cancer cells from deactivating T-cells. This “releases the brakes” on the immune system, allowing T-cells to recognize and attack cancer cells.
Major Clinical Trial Findings by Cancer Type
Opdivo has demonstrated efficacy across various cancer types.
Melanoma
In melanoma, the CheckMate -067 trial showed Opdivo’s benefit. After five years, 44% of patients treated with Opdivo alone were still alive, compared to 26% for those on Yervoy alone. Adverse events were common.
Non-Small Cell Lung Cancer (NSCLC)
For non-small cell lung cancer (NSCLC), Opdivo improved survival outcomes. Patients receiving Opdivo had longer survival compared to those receiving docetaxel, a chemotherapy drug. Common side effects included fatigue, rash, and decreased appetite.
Renal Cell Carcinoma (RCC)
In renal cell carcinoma (RCC), Opdivo showed positive results. The CheckMate-025 trial indicated improved overall survival with Opdivo compared to everolimus in previously treated advanced RCC patients. Serious adverse reactions included intestinal obstruction and acute kidney injury.
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Opdivo has also been approved for recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum-based therapy. The Phase 3 CheckMate -141 trial demonstrated a 30% reduction in the risk of death with Opdivo, with a median overall survival of 7.5 months, compared to 5.1 months for standard therapies. Common adverse reactions included rash, musculoskeletal pain, and pruritus.
Investigating Opdivo in Combination Therapies
Beyond its use as a single agent, Opdivo is studied and administered in combination with other anti-cancer treatments. This approach leverages distinct mechanisms of action, aiming for synergistic effects to enhance tumor response and overcome resistance.
Opdivo with Yervoy
A prominent combination involves Opdivo with Yervoy (ipilimumab), another immunotherapy that targets a different immune checkpoint (CTLA-4). This combination aims to further unleash the immune system’s anti-tumor activity. For advanced melanoma, the Opdivo plus Yervoy combination in the CheckMate -067 trial demonstrated a 5-year overall survival rate of 52%. However, combining these immunotherapies can increase immune-mediated adverse reactions, such as severe diarrhea, colitis, and pyrexia.
Opdivo with Chemotherapy
Opdivo is also combined with chemotherapy, particularly in non-small cell lung cancer. In the CheckMate -816 trial, combining Opdivo with platinum-doublet chemotherapy before surgery in resectable NSCLC patients significantly improved event-free survival, with a median of 43.8 months compared to 18.4 months for chemotherapy alone. This combination demonstrated a 4-year overall survival rate of 71% versus 58% for chemotherapy alone. Serious adverse reactions included pneumonia and vomiting.
Finding and Participating in Opdivo Clinical Trials
Individuals interested in finding or participating in Opdivo clinical trials have resources available. A primary resource is ClinicalTrials.gov, a website maintained by the National Library of Medicine, providing a comprehensive database of clinical studies. Users can search for trials by drug name, cancer type, and location.
Consulting with an oncologist or healthcare provider is also important. They can offer personalized advice, discuss eligibility criteria, and help assess the potential risks and benefits of trial participation. Organizations like the National Cancer Institute (NCI) also provide information and connections to clinical research.