Nivolumab for Advanced Cervical Cancer

Not currently recruiting at 369 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Autoimmune disease, Brain metastases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 92 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the drug nivolumab for individuals with advanced cervical cancer that has returned, grown, or spread. Nivolumab, a monoclonal antibody, helps the immune system target and stop cancer cells. The trial examines both the effectiveness and side effects of this treatment. Eligible participants have cervical cancer that persists or has spread despite previous treatment. As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group, providing an opportunity to contribute to important findings.

Do I need to stop my current medications for the trial?

The trial requires that any prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted agents, and immunologic agents, must be stopped at least three weeks before joining. Investigational agents must be stopped for at least 30 days before joining. The protocol does not specify other medications, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that nivolumab is likely to be safe for humans?

Research has shown that nivolumab is generally safe for patients with cervical, vaginal, or vulvar cancers, meaning most can use the drug without severe side effects. Studies have identified common side effects such as fatigue, rash, and itching. Although serious side effects are rare, they can occur, as with any treatment.

The FDA has already approved nivolumab for other cancer types, indicating it is usually well-tolerated. However, individual reactions to medications can vary. While many consider nivolumab safe, discussing personal risks with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Nivolumab is unique because it leverages the power of the immune system to combat advanced cervical cancer. Unlike traditional treatments like chemotherapy and radiation, which directly attack cancer cells but can also harm healthy cells, nivolumab is an immune checkpoint inhibitor. It blocks a specific protein on immune cells, reinvigorating them to recognize and destroy cancer cells more effectively. Researchers are excited about nivolumab because it offers a targeted approach that could potentially lead to fewer side effects and improved outcomes for patients with advanced cervical cancer.

What evidence suggests that nivolumab might be an effective treatment for advanced cervical cancer?

Research has shown that nivolumab, which participants in this trial will receive, might help treat advanced cervical cancer. In earlier studies, patients who took nivolumab lived for about 5.5 months without their cancer worsening. Another study found that about half of the patients responded to the treatment, with some showing no signs of cancer afterward. Additionally, many patients lived for more than 21.9 months after starting nivolumab. These results suggest that nivolumab could be a promising treatment option for advanced cervical cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Alessandro D Santin

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

This trial is for patients with persistent, recurrent, or metastatic cervical cancer. Participants must have completed prior treatments and recovered from their effects, have measurable disease as per RECIST 1.1 criteria, and a performance status of 0 or 1. They should not be pregnant or nursing and agree to use contraception. Exclusions include brain metastases under certain conditions, HIV/AIDS, active hepatitis infection, autoimmune diseases requiring treatment, previous nivolumab therapy or similar drugs targeting immune pathways.

Inclusion Criteria

You must have had a scan of the specific area being treated within the past 28 days before enrolling in the trial.

I stopped any cancer treatments at least 3 weeks ago.

I haven't taken any experimental drugs in the last 30 days.

Exclusion Criteria

I do not have current severe digestive system problems.

I have previously been treated with specific immune-targeting cancer drugs.

I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nivolumab intravenously every 2 weeks for a maximum of 46 doses over 92 weeks

92 weeks

Every 2 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

5 years

Every 3 months for 2 years, then every 6 months for 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Nivolumab

Trial Overview The trial is testing the effectiveness of Nivolumab—a monoclonal antibody—in treating cervical cancer that has grown back or spread. It aims to see how well it works by blocking tumor growth in different ways by targeting specific cells.

How Is the Trial Designed?

Group I: Treatment (nivolumab) Experimental Treatment 2 Interventions

Patients receive nivolumab IV over approximately 60 minutes every 2 weeks for a maximum of 46 doses over 92 weeks in the absence of disease progression or unacceptable toxicity.

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

Approved in United States as Opdivo for:

• Advanced or metastatic gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma
• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Hepatocellular carcinoma
• Esophageal squamous cell carcinoma

Approved in European Union as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Published Research Related to This Trial

In a study of 4 patients with advanced cervical cancer treated with pembrolizumab, all patients tolerated the treatment well, with one patient achieving a remarkable 21-month progression-free survival, indicating potential efficacy of this PD-1 inhibitor.

Biomarker analysis revealed that patients with a combined positive score (CPS) for PD-L1 of ≥1 and specific somatic mutations, such as in PIK3CA, may benefit from pembrolizumab, suggesting that further research into predictive biomarkers could enhance patient selection for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor molecular profiling of responders and non-responders following pembrolizumab monotherapy in chemotherapy resistant advanced cervical cancer. Ngoi, NYL., Heong, V., Lee, XW., et al.[2020]

Pembrolizumab is an FDA-approved immune checkpoint inhibitor specifically targeting the PD-1 receptor, showing promise in treating recurrent or metastatic cervical cancer in patients whose tumors express PD-L1.

Clinical studies suggest that pembrolizumab could become a preferred treatment option for advanced cervical cancer, but further research is needed to identify which patients will benefit the most from this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for advanced cervical cancer: safety and efficacy. De Felice, F., Giudice, E., Bolomini, G., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11049060/

Systematic Review on the Effectiveness and Outcomes of ... With a median follow-up time of 19.2 months, the median overall survival (OS) was reported at 21.9 months, and the 12-month PFS rate was 26.3%, ...

2. news.bms.com news.bms.com/news/details/2017/Opdivo-nivolumab-Data-in-Patients-with-Advanced-Cervical-Vaginal-and-Vulvar-Cancers-from-Phase-12-CheckMate--358-Presented-at-ASCO/default.aspx

Opdivo (nivolumab) Data in Patients with Advanced ... The median progression-free survival (PFS) was 5.5 months (95% CI: 3.5 to not reached) and the median overall survival (OS) was not yet reached.

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)04614-8/fulltext

286MO Efficacy of low dose nivolumab in recurrent ... Overall responses were seen in 10 patients (50%) out of which 5 (50%) had stable disease and 5(50%) had a complete response. Median progression free survival ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38667535/

Systematic Review on the Effectiveness and Outcomes of ... This systematic review rigorously assesses the effectiveness and outcomes of various nivolumab treatment regimens within this patient cohort.

5. nature.com nature.com/articles/s41467-023-39383-8

Nivolumab plus chemoradiotherapy in locally-advanced ... The NiCOL phase 1 trial (NCT03298893) is designed to determine the safety/tolerance profile and the recommended phase-II dose of nivolumab with and following ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6823884/

Safety and Efficacy of Nivolumab Monotherapy in ... Nivolumab demonstrated a manageable safety profile in patients with cervical, vaginal, or vulvar cancers. ... advanced cervical cancer ...

7. asco.org asco.org/abstracts-presentations/ABSTRACT370354

Combination of nivolumab with chemoradiotherapy for ... Combination of nivolumab with chemoradiotherapy for locally advanced cervical cancer: NiCOL phase I trial. ... We assessed the safety of concurrent and ...