Metastasis and Primary Directed Therapy for Kidney Cancer

Overseen By Naomi Haas, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

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)

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

Compensation: Varies

Number of Visits: Unknown

23 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Total consolidative MPDT for kidney cancer?

Research suggests that using radiation therapy after targeted treatments can effectively control kidney cancer that has spread to a few locations, with patients showing stable disease and some achieving complete remission without added side effects. ^{1 2 3 4 5}

Is the treatment for kidney cancer safe for humans?

The research articles do not provide specific safety data for the treatment known as Metastasis and Primary Directed Therapy (MPDT) for kidney cancer. They focus on treatment trends, mortality, and effectiveness of various therapies for metastatic renal cell carcinoma, but do not address safety information directly. ^{4 6 7 8 9}

How is the Total consolidative MPDT treatment for kidney cancer different from other treatments?

Total consolidative MPDT (Metastasis and Primary Directed Therapy) is unique because it focuses on treating both the primary kidney tumor and any metastatic sites simultaneously, which is different from traditional approaches that often target only the primary tumor or metastases separately. This comprehensive approach may offer a more effective way to manage metastatic renal cell carcinoma by addressing all cancerous areas at once. ^{1 2 3 4 10}

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%

Research Team

Naomi Haas, MD

Principal Investigator

Penn Medicine

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Metastasis-directed treatment in kidney cancer. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Pushing the limits of metastasis-directed treatment in metastatic renal cell carcinoma in the era of targeted therapy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Observation After Cytoreductive Nephrectomy in Patients With Synchronous Not Completely Resected Metastases of Renal Cell Carcinoma. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Trends of Metastasis-Directed Treatments in Patients with Renal Cell Carcinoma: A Total Population-Based Analysis in Germany in the Era of Targeted Therapies. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Radiation therapy following targeted therapy in oligometastatic renal cell carcinoma. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Mortality According to Treatment in Metastatic Collecting Duct Renal Cell Carcinoma. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

What is standard initial systemic therapy in metastatic renal cell carcinoma? [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Targeted therapy for metastatic renal cell carcinoma: a home run or a work in progress? [2008]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Front-Line Therapy for Metastatic Renal Cell Carcinoma: A Perspective on the Current Algorithm and Future Directions. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Synchronous Metastasis Rates in T1 Renal Cell Carcinoma: A Surveillance, Epidemiology, and End Results Database-based Study. [2022]