Metastasis and Primary Directed Therapy for Kidney Cancer

Overseen By Naomi Haas, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Must be taking: Immune checkpoint blockers

Disqualifiers: Progression on therapy, Urgent therapy need, Pregnancy

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment approach for individuals with kidney cancer that has spread. It examines whether stopping ongoing cancer medication after procedures like surgery or radiotherapy can help patients live without treatment for a year. The trial seeks participants whose cancer has not worsened after at least six months of specific immune-based treatments and who have no more than five areas of cancer spread. The treatment under investigation is called Total Consolidative MPDT (Metastasis and Primary Directed Therapy). As an unphased trial, this study allows patients to contribute to innovative research that could lead to new treatment strategies.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that consolidation surgery and biopsies should be within 42 days of holding systemic therapy. This suggests you may need to pause certain treatments.

What prior data suggests that total consolidative MPDT is safe for patients with metastatic clear cell RCC?

Research has shown that the complete treatment plan for kidney cancer, known as MPDT, is generally well-tolerated. Some studies suggest that patients with kidney cancer can manage its side effects. While specific details on side effects are not provided, the treatment includes standard methods such as surgery, freezing cancer cells, and using radiation to kill cancer cells. These methods are typically safe, though they carry known risks. As this is a phase II study, earlier trials likely demonstrated the treatment's safety for further testing. However, individual experiences may vary. Patients should always discuss possible risks with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for metastatic kidney cancer, which often focus solely on systemic therapy, Total Consolidative MPDT takes a more comprehensive approach. This treatment combines surgery, cryoablation, and radiotherapy to directly target both the primary tumor and metastases. Researchers are excited because this method aims to consolidate and potentially eliminate cancer sites in a coordinated fashion, which could lead to improved outcomes by reducing the cancer's ability to spread or return.

What evidence suggests that total consolidative MPDT is effective for metastatic kidney cancer?

Research shows that total consolidative metastasis-and-primary directed therapy (MPDT), which participants in this trial will receive, can be effective for kidney cancer patients. Studies have found that over 90% of patients who received similar treatments had their cancer controlled in the treated area, meaning it did not grow back there. One study found that people with advanced kidney cancer lived for about 38.6 months on average after receiving these treatments. This suggests that MPDT might help prevent the cancer from returning and could extend the lives of some patients. While more research is needed, these findings offer hope that MPDT could be a promising option for those with advanced kidney cancer. ^{1 4 6 7 8}

Who Is on the Research Team?

Naomi Haas, MD

Principal Investigator

Penn Medicine

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immune Checkpoint Blockade Therapy

Participants receive immune checkpoint blockade-based therapy for metastatic clear cell RCC

6 months

Total Consolidative MPDT

Participants undergo total consolidative metastasis-and-primary directed therapy, including surgery, percutaneous cryoablation, and/or radiotherapy

Varies based on procedure

Treatment-Free Survival Monitoring

Participants are monitored for treatment-free survival, defined as the time from discontinuation of anti-cancer therapy until resumption of systemic therapy, additional focally-directed therapy, or death

Up to 60 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Total consolidative MPDT

Trial Overview 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.

How Is the Trial Designed?

Group I: Total consolidative MPDT Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Published Research Related to This Trial

Recent advancements in treating metastatic renal cell carcinoma have led to improved outcomes through combination therapies, particularly those involving immune checkpoint inhibitors and VEGFR-directed therapies.

These combination therapies have resulted in prolonged overall survival and durable responses, marking a significant evolution in the front-line treatment options approved by the FDA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Front-Line Therapy for Metastatic Renal Cell Carcinoma: A Perspective on the Current Algorithm and Future Directions. Govindarajan, A., Castro, DV., Zengin, ZB., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06770855

Study Details | NCT06770855 | Consolidative Metastasis ... From completion of total consolidative MPDT until investigator-assessed disease recurrence, assessed up to 60 months. Other Outcome Measures ...

2. withpower.com withpower.com/trial/phase-2-carcinoma-2025-d66f8

Metastasis and Primary Directed Therapy for Kidney Cancer ... Total consolidative MPDT will have tolerable side effects & efficacy for patients with Renal Cell Carcinoma and Kidney Cancer. Learn more about the study.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10318269/

Survival in Metastatic Renal Cell Carcinoma Treated With ... Our results are consistent with a large series by Wardak et al, who found that in 268 patients with mRCC BM managed with SRT, rates of LC were >90%, and over ...

4. ascopubs.org ascopubs.org/doi/10.1200/EDBK_279881

Current Approaches to the Treatment of Advanced or ... Although median overall survival was an exploratory outcome, it was found to be 38.6 months. A randomized study powered to confirm this finding ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2588931125000847

Predictive Factors for Oligometastatic Renal Cell ... Since the 1990s, several studies across multiple primary cancer sites have indeed confirmed the benefit of consolidative metastasis-directed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11172287/

First-Line Treatments and Management of Metastatic Renal ... Among patients in the ITT population, 22.4% had IMDC favorable-risk, 57.8% had intermediate-risk, and 19.8% had poor-risk prognostic features; ...

7. ascopubs.org ascopubs.org/doi/10.1200/OP-25-00278

Treatment Patterns, Costs, and Outcomes The treatment landscape for patients with metastatic renal cell carcinoma (mRCC) following immuno-oncology (IO) and vascular endothelial growth ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1558767323001751

Outcomes of Consolidative Nephrectomy following Primary ... A total of 40 (71.4%) patients were intermediate IMDC risk. Patients were treated with immunotherapy for median duration of 8.1 months. Immunotherapy resulted ...