Pembrolizumab + Liver-Directed/PRRT for Liver Cancer

Recruiting in San Francisco (>99 mi)

Overseen byNicholas Fidelman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Nicholas Fidelman, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests a combination of pembrolizumab and liver-targeted treatments or PRRT for patients with specific liver-spread neuroendocrine tumors. The treatments aim to boost the immune system and directly attack tumors. It focuses on patients whose tumors are difficult to treat with standard methods. Everolimus has demonstrated effectiveness in neuroendocrine neoplasms and has shown a synergistic effect with radiation therapy.

Eligibility Criteria

This trial is for adults with well-differentiated neuroendocrine tumors that have spread to the liver. Participants must show tumor progression, have a life expectancy over 3 months, and adequate organ function. They should not be pregnant or breastfeeding and agree to use contraception. Exclusions include severe liver involvement by the tumor, active infections, certain medical treatments within specific timeframes before the trial starts, and known allergies to pembrolizumab.

Inclusion Criteria

I am using two birth control methods or am not having sex to join this study.

I am 18 years old or older.

I have a well-differentiated neuroendocrine tumor.

+8 more

Exclusion Criteria

I have active, untreated Hepatitis B.

I have not received a live vaccine within the last 30 days.

I have had peptide receptor radionuclide therapy before.

+18 more

Participant Groups

The effectiveness of combining pembrolizumab (an immunotherapy drug) with either liver-directed therapies (like arterial embolization or radioembolization using Yttrium-90) or peptide receptor radionuclide therapy using 177Lu-DOTA0-Tyr3-Octreotate is being tested in patients with neuroendocrine tumors and liver metastases. The goal is to see if this combination works better than pembrolizumab alone.

3Treatment groups

Experimental Treatment

Group I: Group III [pembrolizumab, yttrium-90 microsphere RE] (CLOSED)Experimental Treatment2 Interventions

Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest measuring more than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo yttrium-90 microsphere Radio Embolization (RE) 3-15 days following the first dose of pembrolizumab.

Group II: Group II [pembrolizumab, TAE] (CLOSED)Experimental Treatment2 Interventions

Patients receive pembrolizumab as in Group I. Patients with any number of liver lesions, largest being no larger than 5 cm, who have \< 75% liver parenchyma replacement by tumors, undergo Arterial Embolization (TAE) over 2-3 hours, 3-7 days following the first dose of pembrolizumab.

Group III: Group I [pembrolizumab, 177Lu DOTATATE]Experimental Treatment2 Interventions

Patients will be treated with pembrolizumab and intravenous peptide receptor radionuclide therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE, Lutathera®) for up to four (4) sessions. Patients with somatostatin receptor positive (SSTR+) tumors with Ki-67 index \> 20% (well-differentiated grade 3) and any number of liver and/or extrahepatic lesions with liver parenchyma replacement by tumor \< 75%. Patients who achieve progressive or stable disease response after cycle 4 may receive an additional 4 cycles of pembrolizumab and lutetium Lu-177 DOTATATE in the absence of disease progression or unacceptable toxicity and pembrolizumab for up to 35 cycles.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: