What side effects are associated with this type of intervention?

The most common treatments for Neuroendocrine Carcinoma, such as NP-101 TQ Formula, Nivolumab, and Ipilimumab, have distinct side effect profiles. NP-101 TQ Formula, with its anti-oxidant and anti-angiogenic properties, lacks detailed side effect documentation. Nivolumab, a PD-1 inhibitor, often causes fatigue, pruritus, and nausea, with severe cases of pneumonitis and colitis. Ipilimumab, a CTLA-4 inhibitor, can result in immune-related adverse events like dermatitis, enterocolitis, hepatitis, and endocrinopathies. Both Nivolumab and Ipilimumab require careful monitoring for severe immune-mediated side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Neuroendocrine Carcinoma that align with the mechanisms of action studied in the NP-101 TQ Formula trial. Nivolumab, a PD-1 inhibitor, and Ipilimumab, a CTLA-4 inhibitor, have been approved for various cancers, including melanoma, and are being explored for their efficacy in Neuroendocrine Carcinoma. Additionally, anti-angiogenic agents like Everolimus have been approved for advanced neuroendocrine tumors, demonstrating the FDA's recognition of these mechanisms in cancer treatment.

What other types of research exist?

Promising novel alternatives for Neuroendocrine Carcinoma patients in 2024 include: 1) Pembrolizumab (PD-1 inhibitor) combined with Lenvatinib (VEGFR inhibitor), which has shown efficacy in various cancers including endometrial cancer. 2) Atezolizumab (PD-L1 inhibitor) combined with Bevacizumab (anti-VEGF), which has demonstrated benefits in renal cell carcinoma and may be applicable to NEC. 3) Durvalumab (PD-L1 inhibitor) combined with Tremelimumab (CTLA-4 inhibitor), particularly for patients with high tumor mutational burden. These combinations leverage different mechanisms to enhance anti-tumor activity and may offer new hope for NEC patients.

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Checkpoint Inhibitor

NP-101 + Nivolumab + Ipilimumab for Cancer

Phase 1

Waitlist Available

Led By Amr Mohamed, MD

Research Sponsored by Amr Mohamed MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years from the start of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a black seed oil formula combined with two cancer drugs in patients with neuroendocrine carcinoma who did not respond to standard treatments. The formula may enhance the immune system's ability to fight cancer and inhibit tumor growth. Thymoquinone (TQ), the major active ingredient of black seed oil, has been extensively studied for its anti-cancer properties, including promoting apoptosis, arresting the cell cycle, and generating reactive oxygen species.

Who is the study for?

Adults with advanced or metastatic high-grade neuroendocrine carcinomas outside the lungs who have tried at least one treatment without success. They must be in good health otherwise, with normal organ and marrow function, and no unresolved severe side effects from previous treatments. Participants need measurable disease by RECIST criteria, agree to use effective contraception methods if of childbearing potential, and sign a consent form.

What is being tested?

The trial is testing a combination of NP-101 (TQ Formula), derived from black seed with antioxidant properties, along with two immunotherapy drugs: Nivolumab and Ipilimumab. This second-line therapy aims to assess its effectiveness against tumors that didn't respond to initial treatments.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs due to Nivolumab and Ipilimumab such as inflammation or dysfunction; fatigue; skin issues; hormonal changes; digestive disturbances; increased risk of infections; allergic reactions similar to those caused by compounds related to the study medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years from the start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years from the start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from the start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Antitumor activity of NP-101 (TQ Formula) plus nivolumab and ipilimumab in subjects with advanced and/or metastatic EP-NECAs who progressed on first line therapy

Secondary study objectives

Safety profile/toxicity of combining NP-101 (TQ Formula) with nivolumab and ipilimumab.

Time to progression (TTP)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NP-101 (TQ Formula) + Nivolumab + IpilimumabExperimental Treatment3 Interventions

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Neuroendocrine Carcinoma include NP-101 TQ Formula, Nivolumab, and Ipilimumab. NP-101 TQ Formula has anti-oxidant and anti-angiogenic effects, reducing oxidative stress and inhibiting new blood vessel formation essential for tumor growth. Nivolumab, a PD-1 inhibitor, enhances the immune system's ability to attack cancer cells by blocking the programmed cell death protein 1 pathway. Ipilimumab, a CTLA-4 inhibitor, prevents the downregulation of T cells, boosting the immune response against cancer cells. These treatments are significant for Neuroendocrine Carcinoma patients as they provide a comprehensive approach to inhibiting tumor growth and enhancing immune system activity.