Nivolumab + Pembrolizumab for Solid Tumor Cancers

Overseen By KUCC Nurse Navigation

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Kansas Medical Center

Must be taking: Pembrolizumab, Nivolumab

Must not be taking: Other immunotherapies

Disqualifiers: Pregnancy, Psychiatric illness, Active infection, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 2

Duration: 12 months

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two different dose levels of the immunotherapy drugs Nivolumab and Pembrolizumab for individuals with solid tumor cancers. The researchers aim to determine whether higher doses of these drugs lead to more immune-related side effects compared to lower doses. Participants must have a confirmed diagnosis of a solid tumor cancer and be eligible for treatment with either drug. This trial may suit those experienced with solid tumors and interested in how different doses might affect treatment outcomes. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

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

The trial protocol does not specify if you need to stop your current medications. However, standard of care combination agents like chemotherapy, targeted therapy, and biologics are allowed, as the main focus is on immune-related side effects.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Nivolumab is generally well-tolerated in patients with solid tumors. About 21% of patients reported serious side effects when combined with other cancer treatments. Common side effects include fatigue, muscle pain, and itching.

Research on Pembrolizumab indicates a consistent safety record. Approximately 74.3% of patients experienced some side effects, mostly manageable, such as fatigue and rash. Serious reactions were rare, occurring in 4% of younger patients and 7% of older patients.

Both treatments have been approved for use in other types of cancer, suggesting relative safety for solid tumors. However, higher doses might increase immune system-related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Nivolumab and Pembrolizumab for solid tumor cancers because these treatments are part of a new class of cancer therapies known as immune checkpoint inhibitors. Unlike traditional chemotherapy, which directly kills cancer cells, these drugs work by helping the immune system recognize and attack cancer cells. Nivolumab and Pembrolizumab specifically target proteins that can prevent the immune system from attacking the tumor, potentially leading to a more robust and lasting response in patients. This mechanism offers a promising alternative for patients who may not respond well to existing treatments.

What evidence suggests that this trial's treatments could be effective for solid tumor cancers?

Research has shown that nivolumab effectively treats various types of cancer. It has significantly increased survival rates for patients with head and neck cancers and melanoma. Patients have reported that it helps control the disease and sometimes improves their quality of life. In this trial, participants may receive nivolumab as part of their treatment regimen. Similarly, pembrolizumab has provided long-term survival benefits for people with advanced melanoma and has proven effective for some patients with other solid tumors. It has lowered the risk of death and provided lasting positive effects in many cases. Participants in this trial may also receive pembrolizumab. Both treatments enhance the body's immune system to fight cancer, leading to promising results in several studies. ^{2 6 7 8 9}

Who Is on the Research Team?

Anup Kasi, MD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

Adults over 18 with solid tumor cancers, regardless of treatment stage, can join this trial. They must have a performance status showing they're still active and not bedridden. Women who can have children need a negative pregnancy test before starting. Participants should be able to receive Pembrolizumab or Nivolumab and understand the study's consent.

Inclusion Criteria

I understand the study and agree to sign the consent form.

I am 18 years old or older.

I can take care of myself and am up and about more than 50% of my waking hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive immunotherapy with varying doses of Pembrolizumab or Nivolumab

12 months

Every 2-6 weeks depending on dose schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-3 years

What Are the Treatments Tested in This Trial?

Interventions

• Nivolumab
• Pembrolizumab

Trial Overview This Phase 3/4 study tests if higher doses of immunotherapies (Pembrolizumab every 6 weeks or Nivolumab every 4 weeks) cause more side effects compared to lower doses (every 3 weeks for Pembrolizumab, every 2 weeks for Nivolumab). It's an open label trial where everyone knows which treatment they get.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 2 Interventions

Nivolumab Cohort- Dose: 480 mg Route: IV Schedule: Once every 4 weeks Overall Treatment Duration per Participant: Average of 12 months Cycle length: Per SOC (4 weeks) Pembrolizumab Cohort- Dose: 400 mg Route: IV Schedule: Once every 6 weeks Overall Treatment Duration per Participant: Average of 12 months Cycle length: Per SOC (6 weeks)

Group II: Arm 1 Experimental Treatment 2 Interventions

Pembrolizumab Cohort- Dose: 200 mg Route: IV Schedule: Once every 3 weeks Overall Treatment Duration per Participation: Average of 12 months Cycle Length: Per SOC (3 weeks) Nivolumab Cohort- Dose: 240 mg Route: IV Schedule: Once every 2 weeks Overall Treatment Duration per Participation: Average of 12 months Cycle Length: Per SOC (2 weeks)

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7699139/

Real-World, Long-Term Outcomes of Nivolumab Therapy ... Efficacy of nivolumab in R/M SCCHN was demonstrated in a phase 3 trial (CheckMate 141 study) [1]. Nivolumab was approved for recurrent or metastatic head and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0305737218301361

Patient-reported outcomes with nivolumab in advanced ... Nivolumab showed sustained stabilization across all tumor types and, in some cases, clinically meaningful improvement in HRQoL, whereas standard of care ...

3. news.bms.com news.bms.com/news/details/2021/Six-and-a-Half-Year-Outcomes-for-Opdivo-nivolumab-in-Combination-with-Yervoy-ipilimumab-Continue-to-Demonstrate-Durable-Long-Term-Survival-Benefits-in-Patients-with-Advanced-Melanoma/default.aspx

Six-and-a-Half-Year Outcomes for Opdivo (nivolumab) in ... Among patients with BRAF-mutant tumors, the rate of OS at 6.5 years was 57% in patients who received Opdivo plus Yervoy, 43% for Opdivo alone, ...

4. opdivohcp.com opdivohcp.com/efficacy

Efficacy Information | OPDIVO® (nivolumab) In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, ...

5. ono-pharma.com ono-pharma.com/sites/default/files/en/news/press/sm_cn160524_1.pdf

Two-Year Overall Survival Data from Two Pivotal Opdivo Across the clinical trial experience with solid tumors, fatal immune-mediated pneumonitis occurred with OPDIVO. In addition, in Checkmate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12290226/

Evaluation of safety outcomes between nivolumab ... These patients were receiving nivolumab treatment for solid tumor cancers. The rate of irAEs was reduced from 51.7% (the rate prior to ...

7. opdivohcp.com opdivohcp.com/

OPDIVO® (nivolumab) | Healthcare Professional Website In Checkmate 77T, serious adverse reactions occurred in 21% of patients who received OPDIVO in combination with platinum-doublet chemotherapy as neoadjuvant ...

8. cancertherapyadvisor.com cancertherapyadvisor.com/news/opdivo-qvantig-approved-to-treat-solid-tumor-malignancies/

Opdivo Qvantig Approved to Treat Solid Tumor Malignancies Safety outcomes were generally similar between the arms. The most common adverse events observed were fatigue, musculoskeletal pain, pruritus, ...

9. onclive.com onclive.com/view/subcutaneous-nivolumab-sustains-comparable-efficacy-safety-to-iv-formulation-in-advanced-ccrcc

Subcutaneous Nivolumab Sustains Comparable Efficacy ... Additional data from the updated analysis showed that the median progression-free survival (PFS) was 6.3 months with subcutaneous nivolumab vs ...