What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, such as immunotherapy (e.g., pembrolizumab), chemotherapy, and radiation therapy, have various side effects. Immunotherapy can cause immune-related adverse events like skin reactions, colitis, hepatitis, and endocrinopathies. Chemotherapy often leads to nausea, vomiting, mucositis, and myelosuppression. Radiation therapy can result in mucositis, xerostomia, dysphagia, and skin reactions. Combination therapies may increase the incidence and severity of these side effects.

What prior FDA approvals exist?

FDA-approved treatments for Head and Neck Cancers that have direct anti-tumor effects and potential immune response enhancement include pembrolizumab and cetuximab. Pembrolizumab, an anti-PD-1 antibody, has been approved for its ability to enhance the immune system's response against tumor cells. Cetuximab, an EGFR inhibitor, has shown benefits in combination with chemotherapy, improving overall survival and progression-free survival in patients. These treatments align with the mechanisms being studied in the CyPep-1 trial, which aims to evaluate the efficacy of direct tumor injection and immune response enhancement.

What other types of research exist?

Promising alternatives to CyPep-1 for head and neck cancer patients include: 1) Pembrolizumab, either alone or in combination with chemotherapy, as it has shown efficacy in improving overall survival and progression-free survival in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048 study). 2) Cetuximab combined with cisplatin and paclitaxel, which has been investigated for its efficacy and safety in first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (B490 study). 3) Nivolumab plus ipilimumab, which has shown promise in improving survival in patients with PD-L1-positive tumors. These treatments focus on enhancing the immune response and directly targeting tumor cells.

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Peptide

CyPep-1 + Pembrolizumab for Advanced Cancers (Catalyst Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Cytovation AS

Eligibility Criteria Checklist

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

Must have

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Is 18 years of age or older on the day of signing informed consent

Must not have

Has had a prior allogeneic tissue/solid organ transplant, stem cell, or bone marrow transplant

Has a QTcF >480 ms at screening, history of long or short QT syndrome, Brugada syndrome, QTc prolongation, or Torsade de Pointes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment that injects a special protein and an immune-boosting drug into tumors. It targets patients with advanced or hard-to-treat cancers. The treatment helps the immune system recognize and attack cancer cells.

Who is the study for?

Adults with advanced or metastatic cancers such as head and neck, breast, melanoma, or squamous cell carcinoma. Participants must have a measurable tumor for injection, be able to provide biopsy tissue, have an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and adequate organ function. Pregnant women, those with recent cancer treatments or surgeries, certain infections like HIV/SARS-CoV-2/Hepatitis B/C, autoimmune diseases requiring immunosuppression within the last two years are excluded.

What is being tested?

The trial is testing CyPep-1 injected into tumors combined with pembrolizumab (Keytruda) infusion. It aims to evaluate how safe and effective this combination is against various cancers by observing its impact on both treated and untreated tumor sites as well as overall immune response.

What are the potential side effects?

Potential side effects may include reactions at the injection site for CyPep-1 and typical immune-related adverse effects from pembrolizumab such as fatigue, skin issues, inflammation of organs like lungs (pneumonitis), liver problems; also possible are flu-like symptoms and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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I have a tumor that can be reached for injection and is not an open sore.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a transplant of tissue, organ, stem cell, or bone marrow.

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I have a heart condition related to abnormal heart rhythms.

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I am allergic to ingredients in CyPep-1 or pembrolizumab.

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My cancer has spread to 4 or more places, including where it started.

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I am not under legal protection, vulnerable, or unable to give informed consent.

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I have or had lung inflammation not caused by infection, treated with steroids.

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I have a history of Hepatitis B or active Hepatitis C.

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I have brain metastases that are causing symptoms or getting worse.

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My skin cancer cannot be felt by touch.

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I haven't had cancer treatment in the last 4 weeks (2 weeks for palliative radiotherapy).

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I have not had a live vaccine within 30 days before starting CyPep-1.

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I am currently being treated for an infection.

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I have another cancer that is growing or needs treatment, except for early skin cancer or carcinoma in situ.

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I am HIV positive.

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I haven't needed immunosuppressive therapy for an autoimmune disease in the last 2 years.

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I have not had major surgery in the last 2 weeks.

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I will need cancer treatment during the study, but not just local pain relief radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C: advanced or metastatic TNBCExperimental Treatment2 Interventions

The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic TNBC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).

Group II: Arm B: advanced or metastatic melanomaExperimental Treatment2 Interventions

The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic melanoma. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).

Group III: Arm A: advanced or metastatic HNSCCExperimental Treatment2 Interventions

The safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic HNSCC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CyPep-1

2020

Completed Phase 2

~70

Pembrolizumab 25 MG/ML [KEYTRUDA®]

2020

Completed Phase 2

~70

0 / 20Eligibility criteria met

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

Common treatments for Head and Neck Cancers include surgery, radiation therapy, chemotherapy, and immunotherapy. Surgery aims to physically remove the tumor, while radiation therapy uses high-energy rays to kill cancer cells. Chemotherapy involves drugs that target rapidly dividing cells, including cancer cells. Immunotherapy, such as pembrolizumab, enhances the body's immune response against cancer by inhibiting the PD-1 pathway, which tumors use to evade immune detection. The investigational treatment CyPep-1, when combined with pembrolizumab, is designed to have direct anti-tumor effects and potentially enhance systemic immune responses. This dual approach is significant for patients as it may improve the efficacy of treatment by not only targeting the tumor directly but also by boosting the body's natural defenses against cancer.