Recruiting

MPDT

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06770855

Conditions

Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Total consolidative MPDT

Study Details

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 ID

NCT06770855

Start date

Jun 12, 2026

Status verified date

Jun, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

23 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

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).

Primary outcome measure

  • Treatment-free survival [ Time Frame: From discontinuation of anti-cancer therapy until resumption of systemic therapy, first date of additional focally-directed therapy or death, whichever comes first, assessed up to 60 months. ]

Central Contacts and Locations

Central contacts

Matthew Doyle

610-357-6354Matthew.Doyle@Pennmedicine.upenn.edu

Naomi Haas, MD

2156627615Naomi.Haas@pennmedicine.upenn.edu

Locations

Abramson Cancer Center at University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Matthew Doyle

6103576354Matthew.Doyle@Pennmedicine.upenn.edu

Naomi Haas

215-662-7615Naomi.Haas@pennmedicine.upenn.edu

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Oct 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.