Phase II Multi-center Clinical Study of PD-1 Inhibitor Combined With Hypofractionated Radiotherapy and GM-CSF With IL-2(PRaG2.0 Regimens) Rechallenge for Patients With Resistance to PD1/PD-L1 Inhibitors in Refractory Advanced Solid Tumors.

NCT05530200 Phase 2 UNKNOWN

Finding an effective treatment to rescue with resistance of PD-1/PD-L1 inhibitor has been an urgent problem.The PRaG trial as a salvage therapy in advanced solid tumors has obtained satisfactory results.We found that patients with PD-1/PD-L1 inhibitors resistance are more likely to benefit from the PRaG regimens(PD-1 inhibitors combined with radiotherapy and GM-CSF with IL-2). Further phase II clinical trial was conducted to confirm the efficacy and safety of PRaG regimen rechallenge for patients with resistance to PD1/PD-L1 inhibitors in refractory advanced solid tumors.

Details

Lead sponsor	Second Affiliated Hospital of Soochow University
Phase	Phase 2
Status	UNKNOWN
Enrolment	56
Start date	2022-09
Completion	2025-06

Conditions

• Metastatic Solid Tumor

Interventions

• Hypofractionated radiotherapy
• PD-L1 inhibitor
• GM-CSF
• IL-2

Primary outcomes

• ORR — Up to 3 years
  objective response rate