Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma

Recruiting at 8 trial locations

Overseen By Mark DeBenedette, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CoImmune

Must not be taking: Immunosuppressants

Disqualifiers: Brain metastases, Cardiovascular conditions, Autoimmune disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 35

16 Participants Needed

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 your current medications, but it mentions that you must be able to abstain from taking prohibited drugs during the treatment phase. It's best to discuss your specific medications with the trial team.

What is the purpose of this trial?

This trial tests a personalized cancer treatment for advanced kidney cancer patients. It uses the patient's own immune cells, modified to target their specific cancer, to help the immune system fight the disease. The treatment is combined with other drugs to improve effectiveness.

Eligibility Criteria

Inclusion Criteria

Advanced disease histologically assessed as RCC, with predominantly clear cell histology

Adequate renal function, as defined by either of the following criteria:

Adequate hepatic function, as defined by both of the following:

Exclusion Criteria

Pregnancy or breastfeeding

Prior history of malignancy within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer, adequately treated early stage breast cancer, superficial bladder cancer, and non-metastatic prostate cancer with a normal PSA

You have a history of cancer spreading to the brain or spinal cord, or signs of cancer in the brain or protective covering of the brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Induction

CMN-001 dosing initiated during 1st line therapy, administered as 1 dose every 3 weeks for 3 doses

9 weeks

3 visits (in-person)

Maintenance

CMN-001 maintenance doses, 1 every 4 weeks for 7 doses

28 weeks

7 visits (in-person)

Booster

CMN-001 booster doses, 1 dose every 12 weeks

Long-term

Every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Through study completion, an average of 2 years

Every 12 weeks

Treatment Details

Interventions

• CMN-001

Participant Groups

Group I: Combination Arm Experimental Treatment 3 Interventions

CMN-001 dosing (1x10\^7 DC/dose) is initiated at Visit 2 during 1st line therapy and through 2nd line therapy. CMN-001 is administered as 1 dose every 3 weeks for 3 doses (Induction phase), followed by maintenance doses, 1 every 4 weeks for 7 doses (Maintenance phase), followed by booster doses, 1 dose every 12 weeks (Booster phase). 1st line therapy, Nivolumab (3mg/kg) + Ipilimumab (1 mg/kg) will be administered at 3 week intervals for 4 administrations starting at visit 1. Followed by Nivolumab (3 mg/kg) administration every 4 weeks until progression. After progression, 2nd line therapy with lenvatinib (18mg/day) + everolimus (5mg/day) until discontinuation criteria are met.

Group II: Standard Treatment Active Control 2 Interventions

1st line therapy, Nivolumab (3mg/kg) + Ipilimumab (1 mg/kg) will be administered at 3 week intervals for 4 administrations starting at visit 1. Followed by Nivolumab (3 mg/kg) administration every 4 weeks until progression. After progression 2nd line therapy with lenvatinib (18mg/day) + everolimus (5mg/day) until discontinuation criteria are met.

Who Is Running the Clinical Trial?

CoImmune

Lead Sponsor

Trials

1

Recruited

20+