Consolidative Metastasis and Primary Directed Therapy (MPDT) for Renal Cell Carcinoma (RCC)

NCT ID: NCT06770855

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-11
• Study Completion Date: 2028-09-30

Brief Summary

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%

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Total consolidative MPDT

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).

Group Type: EXPERIMENTAL

Total consolidative MPDT

Intervention Type: PROCEDURE

After stopping systemic anti-cancer therapy for metastatic RCC, participant will receive one or more of the following: surgery (e.g. nephrectomy, metastasectomy, lymph node dissection), percutaneous cryoablation and/or radiotherapy (SAbR or other definitive radiotherapy).

Interventions

Total consolidative MPDT

After stopping systemic anti-cancer therapy for metastatic RCC, participant will receive one or more of the following: surgery (e.g. nephrectomy, metastasectomy, lymph node dissection), percutaneous cryoablation and/or radiotherapy (SAbR or other definitive radiotherapy).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma (mixed histology acceptable but must have clear cell component)
• Metastatic clear cell RCC with 5 or fewer metastases at enrollment (excluding pulmonary nodules <1.0cm)
• Stable disease or partial response as assessed by investigators following at least 6 months of immune checkpoint blockade-based therapy.
• Has disease amenable for total consolidative focal therapy (this will be determined by a multidisciplinary team which may include a combination of medical oncologists, urologists, interventional radiologists, and radiation oncologists).
• ECOG performance status < 2
• Must have archival tissue (slide or Formalin-Fixed Paraffin-Embedded tissue) preceding prior systemic treatment for comparison to tissue from consolidation
• Consolidation surgery and biopsies are strongly encouraged to be within 42 days +/- 7 days of holding systemic therapy.

Exclusion Criteria

• Subjects who have progressed during the first 6 months of immune checkpoint-blockade based therapy as determined by study investigator.
• Subjects who have a need for urgent focally directed therapy (i.e. symptomatic brain or spinal metastases). Stable spinal metastases resected and/or treated with SBRT in advance of or concurrently with immune checkpoint-blockade based therapy are allowed to participate.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naomi Haas, MD

Role: PRINCIPAL_INVESTIGATOR

Penn Medicine

Locations

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Central Contacts

Matthew Doyle

Role: CONTACT

Matthew.Doyle@Pennmedicine.upenn.edu

610-357-6354

Naomi Haas, MD

Role: CONTACT

Naomi.Haas@pennmedicine.upenn.edu

2156627615

Facility Contacts

Matthew Doyle

Role: primary

Matthew.Doyle@Pennmedicine.upenn.edu

610-357-6354

Naomi Haas

Role: backup

Naomi.Haas@pennmedicine.upenn.edu

215-662-7615

Other Identifiers

IRB#857362

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 33824

Identifier Type: -

Identifier Source: org_study_id