The Efficacy and Safety of Penpulimab in the Treatment of Metastatic PPGL Patients Who Fail to Other Systemic Treatment

NCT ID: NCT05885399

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-03-01

Brief Summary

Metastatic pheochromocytoma / paraganglioma (MPP) are rare while the prognosis was poor. Penpulimab is specifically an immune check-point inhibitor of PD1 and has been approved for the treatment of several malignancies.This phase II trial studies the efficacy and safety of penpulimab in the treatment of MPP patients who fail to other systemic therapy.

Detailed Description

This was a prospective observational study. Patients with histologically or radiologically confirmed MPP and fail to other systemic therapy were enrolled. Penpulimab will be administered intravenously at a dose of 200 mg every 3 weeks. Treatment continued until the patient exhibited radiographic or clinical disease progression or unacceptable adverse events.Plasma normetanephrine and metanephrine (MNs), 24-hour urinary catecholamine excretion (24hCA) were measured at baseline and every 1-3cycle. Contrast-enhanced computed tomography(CT) of chest, abdomen and pelvis were used to assess measurable target lesions at baseline and every 3 cycles. For patients who only had bone metastases or no measurable target lesions, The efficacy was evaluated by 18F-fluorodeoxyglucose (18F-FDG-PET/CT). The primary endpoint was objective response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria In Solid Tumors(RECIST) 1.1/PERCIST1.0. Secondary endpoints included biochemical (catecholamine levels) response rate (BRR), progression-free survival (PFS) and safety.

Conditions

Pheochromocytoma, Metastatic; Pheochromocytoma Malignant; Paraganglioma, Malignant

Study Design

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

Study Groups

penpulimab

Penpulimab will be administered intravenously at a dose of 200 mg every 3 weeks. Treatment continued until the patient exhibited radiographic or clinical disease progression or unacceptable adverse events.

Group Type: EXPERIMENTAL

Penpulimab

Intervention Type: DRUG

Penpulimab will be administered intravenously at a dose of 200 mg every 3 weeks. Treatment continued until the patient exhibited radiographic or clinical disease progression or unacceptable adverse events.

Interventions

Penpulimab

Penpulimab will be administered intravenously at a dose of 200 mg every 3 weeks. Treatment continued until the patient exhibited radiographic or clinical disease progression or unacceptable adverse events.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provide written informed consent.
• Age 18-75 years old
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
• Patients with histologically or radiologically confirmed MPP and fail to other systemic therapy.
• Estimated life expectancy longer than 6 months.
• Confirmed non-pregnancy and lactation. During the entire study period and within 6 months after the last administration, the subjects and their spouses are willing to use efficient contraceptive measures.
• Laboratory requirements:

• Absolute granulocyte count (AGC) greater than 1.5 x 109/L;
• Platelet count greater than 80 x 109/L;
• Hemoglobin greater than 90g/L;
• Serum bilirubin less than 1.5 x upper limit of normal (ULN);

--)Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN;

• Serum creatinine less than 1.5 x ULN or creatinine clearance (CCr)≥60ml/min;
• Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).

Exclusion Criteria

• Patients who had been previously treated with anti-PD1, anti-PD-L1, or anti-PD-L2 medications were excluded from this trial.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment.
• Has a known history of active TB (Bacillus Tuberculosis).
• Has a known history of Human Immunodeficiency Virus (HIV).
• Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
• Has an active infection requiring systemic therapy.
• Didn't meet eligibility for organ function.
• Abnormal coagulation (INR >1.5 or prothrombin time (PT) > ULN 4 seconds or APTT >1.5 ULN), bleeding tendency or being treated with thrombolytic or anticoagulant therapy.
• Uncontrolled congestive heart failure .

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anli Tong

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Anli Tong

Role: CONTACT

tonganli@hotmail.com

13911413589

Facility Contacts

Anli Tong

Role: primary

tonganli@hotmail.com

13911413589

Other Identifiers

06086-06

Identifier Type: -

Identifier Source: org_study_id