NCT05530200

PRaG Regimens Rechallenge for Patients With Resistance to PD1/PD-L1 Inhibitors in Refractory Advanced Solid Tumors.

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.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patinets with PD-1/PD-L1 inhibitors resistance have limited treatment.ICIs rechallenge is one of the attractive and challenging selection strategies.The efficacy and safety of PD-1/PD-L1 inhibitor rechallenge remain unclear.PRaG regimens realize the sensitization of the efficacy of PD-1 inhibitors, broaden the anti-cancer spectrum of PD-1 immunotherapy, and achieve precise and minimally invasive tumor treatment.PRaG regimens might benefit the survival of patients with resistance to PD1/PD-L1 inhibitors in refractory advanced solid tumors.A phase II clinical study is planned to explore the efficacy and safety of PRaG regimens in advanced refractory solid malignancies after resistance of PD-1/PD-L1 therapy.

Conditions

• Metastatic Solid Tumor

Interventions

Type	Name	Description
RADIATION	Hypofractionated radiotherapy	24Gy/8Gy/3f
DRUG	PD-L1 inhibitor	q3w
DRUG	GM-CSF	200μg, D1-D7
DRUG	IL-2	at a dose of 2 million IU, D8-D14

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2022-09-07
• Last updated: 2022-09-07