Apply to Trial

Compensation: Varies

Number of Visits: 8

Duration: 24 weeks

40 Participants Needed

Ivonescimab for Kidney Cancer

Overseen ByPavlos Msaouel, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: PD-1/PD-L1 inhibitors

Must not be taking: Investigational agents

Disqualifiers: Other malignancies, Hypertension, Cardiac disease, others

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

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications. However, it does allow for certain medications like anticoagulants and treatments for hepatitis B and C, provided they meet specific conditions. It's best to discuss your current medications with the trial team to get a clear answer.

What data supports the effectiveness of the drug Ivonescimab for kidney cancer?

While there is no direct data on Ivonescimab for kidney cancer, other treatments like monoclonal antibodies and kinase inhibitors have shown promise in treating advanced renal cell carcinoma. These treatments have improved response rates and survival in patients, suggesting that similar approaches could be effective.¹ ² ³ ⁴ ⁵

What is the purpose of this trial?

To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ccRCC.

Research Team

Pavlos Msaouel, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults with advanced clear cell renal cell carcinoma (ccRCC) who've had at least one prior systemic treatment, including a PD-1/PD-L1 inhibitor. They must have measurable disease, stable cardiac function, and adequate organ/marrow function. Participants need to understand the study and consent to it, not be pregnant or breastfeeding, use contraception, and have no major diseases or recent surgeries.

Inclusion Criteria

Participants must have at least one measurable site of disease per RECIST version 1.1

INR and PT ≤ 1.5 x ULN and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5 ULN

Participants must have the ability to understand and the willingness to sign a written informed consent document for this clinical trial and companion trials

See 11 more

Exclusion Criteria

Pregnant women, breastfeeding women, and women planning to breastfeed are excluded

History of major diseases prior to enrollment

Participants who are receiving any other investigational agents

See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ivonescimab IV every 3 weeks

24 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Up to 1 year

Treatment Details

Interventions

Ivonescimab

Trial Overview The trial is testing Ivonescimab's effectiveness in controlling ccRCC that has been previously treated but continues to progress. It aims to see if this drug can help patients whose cancer has either locally advanced or spread further (metastatic).

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Cohort 2 - (Post-ICB/VEGFTKI)Experimental Treatment1 Intervention

Treatment with Ivonescimab IV Q3W

Group II: Cohort 1 - (Post-pure-ICB)Experimental Treatment1 Intervention

Treatment with Ivonescimab IV Q3W

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Strategic Alliance

Collaborator

Trials

Recruited

90+

Summit Therapeutics Sub, Inc

Collaborator

Trials

Recruited

50+

Summit Therapeutics

Industry Sponsor

Trials

Recruited

4,500+

Findings from Research

Advanced renal cell carcinoma is resistant to many traditional therapies, but new immunotherapeutic approaches, including monoclonal antibodies and kinase inhibitors, are being explored, showing good tolerance and stable disease rates.

Two recently approved agents, a kinase inhibitor and an mTOR inhibitor, are now recommended as first-line treatments, while sorafenib is suggested for second-line therapy, highlighting the need for further research on their combinations and sequential use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current immunotherapeutic strategies in renal cell carcinoma.Amato, RJ.[2009]

Immunotherapy has been the leading treatment for advanced renal cell carcinoma, but its clinical effectiveness has been largely disappointing, prompting the search for better options.

New agents targeting specific biological abnormalities of renal cell carcinoma are currently being tested in clinical trials, showing promising early results that could improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will the dark sky over advanced renal cell carcinoma soon become brighter?D'Hondt, V., Gil, T., Lalami, Y., et al.[2007]

Sunitinib has been established as the standard first-line treatment for advanced renal cell carcinoma, based on results from a large-scale, long-term Phase III trial.

Conventional treatments like nephrectomy followed by IL-2 or IFN-alpha often do not provide long-term survival benefits, highlighting the importance of targeted therapies like sunitinib in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sunitinib (SUTENT) for the treatment of metastatic renal cell carcinoma.Hutson, TE.[2018]