Metastasis and Primary Directed Therapy for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen byNaomi Haas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Abramson Cancer Center at Penn Medicine

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a non-randomized, open-label phase II study designed to estimate 12-month treatment-free survival rate following total consolidative metastasis-and-primary directed therapy (MPDT) among patients with partial response/stable disease after at least 6 months of immune checkpoint blockade-based therapy for metastatic clear cell RCC. The investigators hypothesize that patients who undergo total consolidative MPDT followed by systemic therapy discontinuation will have a 12-month treatment-free survival rate of 32% compared to a null hypothesis of 13%

Eligibility Criteria

This trial is for individuals with metastatic clear cell Renal Cell Carcinoma (RCC) who have had a partial response or stable disease after 6 months of immune checkpoint blockade therapy. It's not specified who can't join, but typically those with other health issues that could interfere might be excluded.

Inclusion Criteria

My condition can be treated with focused therapy as decided by a team of cancer specialists.

I can do most of my daily activities on my own.

I have saved tissue samples from before my systemic treatment.

+4 more

Exclusion Criteria

I need urgent treatment for cancer that has spread to my brain or spine.

Any female of child-bearing potential who has a positive urine pregnancy test within 72 hours before screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Participants must be excluded/discontinued from the trial in the event of a positive or borderline positive serum pregnancy test result

My cancer got worse within 6 months while on a specific immune therapy.

Participant Groups

The study tests total consolidative MPDT in patients to see if it increases the time they can go without treatment after initial success with immune therapy. The goal is to determine if this approach leads to at least a 32% rate of patients being treatment-free at one year.

1Treatment groups

Experimental Treatment

Group I: Total consolidative MPDTExperimental Treatment1 Intervention

Participants will discontinue systemic anti-cancer therapy for metastatic RCC, and standard of care definitive procedures or metastatic RCC. These procedures include one or more of the following: surgery (e.g. nephrectomy, metastasectomy, lymph node dissection), percutaneous cryoablation and/or radiotherapy (SAbR or other definitive radiotherapy).