Health TrialsbyHealthPanel

Ivonescimab for the Treatment of Thymic Cancer

ConditionThymus Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

This phase II trial tests how well ivonescimab works in treating patients with thymic carcinoma. Immunotherapy with monoclonal antibodies, such as ivonescimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female ≥ 18 years of age and willing and able to provide informed consent

Cytologically or histologically confirmed thymic carcinoma, which is incurable

Received prior systemic therapy for thymic carcinoma, or is ineligible for or refuses other therapies

Measurable disease, as per RECIST 1.1

Disqualifiers

Prior treatment with an immune checkpoint inhibitor targeted PD-1 or PD-L1. Prior treatment with VEGF inhibitor is allowed

Concurrent enrollment in another clinical study, unless enrolled only in the follow-up period or an observational study

Any chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment in the prior 3 weeks or within 5 half-lives of the medication, whichever is shorter. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable

Thoracic radiation of ≥ 30 Gy within 3 months. Other radiation within 3 weeks with the following exceptions: (a) Stereotactic, palliative radiation for bone metastases is acceptable without a washout; (b) Stereotactic brain radiation for asymptomatic brain metastases is acceptable with a 7 day washout

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood and urine samples

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Ivonescimab

    Biological/Vaccine

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment (ivonescimab)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

ORR is defined as complete response or partial response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The ORR estimate and its associated 95% confidence interval will be calculated.

Time frame
Up to 1 year

Secondary outcomes

1

Progression free survival

Cancer progression will be determined per RECIST 1.1.

Time frame
From trial initiation to cancer progression or death due to any cause, assessed up to 1 year
2

Duration of response

Time frame
From documentation of tumor response to disease progression, assessed up to 1 year
3

Time to response

Time frame
From treatment initiation until documentation of tumor response, assessed up to 1 year
4

Overall survival

Time frame
From randomization to death by any cause, assessed up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

Summit Therapeutics

Collaborator

Source ClinicalTrials.gov
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