What side effects are associated with this type of intervention?

Common treatments for cervical cancer, including immunotherapy agents like PD-1 and CTLA-4 inhibitors, can lead to immune-related adverse events such as fatigue, rash, diarrhea, and endocrinopathies. Chemotherapy, another standard treatment, often results in nausea, vomiting, hair loss, fatigue, and increased infection risk. Combining these therapies may intensify these side effects.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of cervical cancer, particularly those targeting the PD-1 pathway. Pembrolizumab, a PD-1 inhibitor, is approved for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. While there are no FDA-approved bispecific antibodies targeting both PD-1 and CTLA-4 specifically for cervical cancer, the approval of pembrolizumab highlights the potential of immunotherapy in this setting. Other treatments, such as bevacizumab, an angiogenesis inhibitor, are also used in combination with chemotherapy for advanced cervical cancer.

What other types of research exist?

Promising novel alternatives to AK104 for cervical cancer patients include: 1) Pembrolizumab (Keytruda), a PD-1 inhibitor, which has shown efficacy in PD-L1 positive cervical cancer. 2) Nivolumab (Opdivo), another PD-1 inhibitor, which has demonstrated benefits in various cancers and is being explored for cervical cancer. 3) Tisotumab vedotin (Tivdak), an antibody-drug conjugate targeting tissue factor, approved for recurrent or metastatic cervical cancer. These treatments offer different mechanisms of action and have shown promising results in clinical trials.

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Monoclonal Antibodies

AK104 for Cervical Cancer

Phase 2

Waitlist Available

Led By Michael Frumovitz

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years at time of study entry

Histologically or cytologically confirmed recurrent or metastatic high grade neuroendocrine carcinoma of the cervix with disease progression confirmed by radiologic imaging during or following prior platinum-based doublet chemotherapy, with or without bevacizumab for recurrent or metastatic cervical cancer

Must not have

Histological types of cervical cancer other than high grade neuroendocrine carcinoma

Brain/central nervous system (CNS) metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing AK104, a treatment that helps the immune system fight cancer, in adults whose high-grade neuroendocrine cervical cancer has come back or spread after previous treatments.

Who is the study for?

Adults over 18 with recurrent or metastatic high-grade neuroendocrine cervical cancer that worsened after platinum-based chemotherapy can join. They should have tried no more than two systemic therapies and not be candidates for surgery/radiation. Participants need measurable lesions, good performance status, proper organ function, a negative pregnancy test if applicable, and agree to use contraception.

What is being tested?

The trial is testing AK104 (Cadonilimab), an investigational drug given as monotherapy to see how effective and safe it is for patients who've had previous treatments for their advanced cervical cancer. It's an open-label study where everyone gets the same treatment.

What are the potential side effects?

While specific side effects of AK104 are not listed here, similar drugs often cause immune-related reactions affecting organs, infusion reactions like fever or chills, fatigue, potential blood abnormalities, increased risk of infections and possibly allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cervical cancer has returned or spread and worsened after platinum-based chemotherapy.

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Surgery or radiation are not options for my recurrent disease.

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I have had 2 or fewer treatments for my cancer after it returned or spread.

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

Exclusion Criteria

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

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My cervical cancer is not a high-grade neuroendocrine type.

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My cancer has spread to my brain or central nervous system.

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I have tested positive for HIV or have active AIDS.

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I have an autoimmune disease that could come back.

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I have a serious heart or brain blood vessel condition.

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I have lingering side effects from previous cancer treatments.

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I have had a stem cell or organ transplant in the past.

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I haven't taken steroids or immunosuppressants in the last 14 days.

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I have had lung conditions not caused by infections.

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I have severe kidney swelling not improved by specific treatments.

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I have an active hepatitis B or C infection.

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

1Treatment groups

Experimental Treatment

Group I: AK104Experimental Treatment1 Intervention

cadonilimab) can help to control neuroendocrine cervical cancer that is recurrent (has come back after treatment) or metastatic (has spread).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AK104

2019

Completed Phase 2

~630

0 / 16Eligibility 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 cervical cancer, particularly advanced or recurrent cases, include immunotherapy agents such as checkpoint inhibitors and bispecific antibodies. Checkpoint inhibitors like pembrolizumab and nivolumab target PD-1 or PD-L1 pathways, enhancing the immune system's ability to recognize and destroy cancer cells. Bispecific antibodies, such as AK104, target multiple immune checkpoints (PD-1 and CTLA-4), potentially offering a more robust immune response against cancer cells. These treatments are significant for cervical cancer patients as they provide new therapeutic options, especially for those who have not responded to traditional therapies, potentially improving survival rates and quality of life.

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