STR + Anti PD-1 Therapy in Patients with Locally Advanced Unresectable Pancreatic Adenocarcinoma

NCT ID: NCT04098432

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-03
• Study Completion Date: 2022-09-30

Brief Summary

Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma

Detailed Description

Phase I/II, multicentre, open label, with no control arm clinical trial of 4-weeks stereotactic radiotherapy followed by nivolumab 3 mg/kg every two weeks in adults with locally advanced pancreatic cancer who does not progress during 4 cycles of standard chemotherapy FOLFIRINOX

Conditions

Locally Advanced Unresectable Pancreatic Adenocarcinoma

Study Design

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

Study Groups

Arm 1

4-weeks stereotactic radiotherapy followed by nivolumab 3 mg/kg every two weeks

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

Nivolumab 3 mg/kg intravenously every two weeks untill disease progression or unacceptable toxicity

Stereotactic radiotherapy

Intervention Type: RADIATION

The prescribed dose will be 32 Gy in four fractions in four weeks (8 Gy per one fraction).

Interventions

Nivolumab

Nivolumab 3 mg/kg intravenously every two weeks untill disease progression or unacceptable toxicity

Intervention Type: DRUG

Stereotactic radiotherapy

The prescribed dose will be 32 Gy in four fractions in four weeks (8 Gy per one fraction).

Intervention Type: RADIATION

Other Intervention Names

Opdivo; Radiation

Eligibility Criteria

Inclusion Criteria

1. Male and female patients aged ≥18 years

2. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1

3. Locally advanced, unresectable, histologically confirmed primary adenocarcinoma of pancreas with no progression during induction chemotherapy (4 cycles of FOLFIRINOX - not a part of trial). Within screening period tumor tissue must be available and sent to the central pathological reviewer in order to confirm the diagnosis.

4. Measurable (one target lesion is sufficient) disease as per RECIST 1.1 criteria

5. Laboratory values:

1. Aspartate aminotransferase (AST) ≤ 3x ULN (upper limit of normal)

2. Alanine transaminase (ALT) ≤ 3x ULN

3. Total bilirubin ≤ 1.5 x ULN (except subjects with Gilbert syndrome who must have a total bilirubin ≤ 3x ULN)

4. Creatinine: Serum creatinine ≤ 1.5 ULN or creatinine clearance > 50ml/min (using Cockcroft/Gault formula)

5. White blood cells ≥ 2000 /ul

6. Neutrophils ≥ 1500 /ul

7. Platelets ≥ 100x 103 /ul

8. Hemoglobin ≥ 9.0 g/l

6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and who is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under age of 55 years must have serum follicle stimulating hormone (FSH) level > 40mIU/ml to confirm menopause.

Exclusion Criteria

1. Other histology then primary pancreatic adenocarcinoma

2. Resectable disease

3. Distant metastases

4. Progressive disease during induction chemotherapy (4 cycles of FOLFIRINOX)

5. Other previous treatment of the disease except induction chemotherapy (4 cycles of FOLFIRINOX)

6. ECOG performance score of 2 or more

7. Previous therapy of malignant disease in 5 years and less before inclusion to the trial (except skin epithelial tumors)

8. Previous radiotherapy in abdominal region

9. Previous immunological treatment (anti-CTLA-4, anti-PD1 or anti-PD-L1)

10. Active, known or suspected serious autoimmune disease

11. Major surgery less than 28 days prior to the first dose of study treatment

12. Treatment of any investigational medicinal product within 4 weeks before this trial enrolment

13. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection

14. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency synrome (AIDS)

15. Prisoners or subjects who are involuntarily incarcerated

16. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

GCP-Service International s.r.o.

UNKNOWN

Sponsor Role: collaborator

University Hospital Hradec Kralove

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Klinika Onkologie a radioterapie, Fakultní nemocnice Hradec Králové

Hradec Králové, , Czechia

Onkologická klinika, Fakultní nemocnice Olomouc

Olomouc, , Czechia

Onkologická klinika, Thomayerova nemocnice

Prague, , Czechia

Ústav radiační onkologie, Nemocnice Na Bulovce

Prague, , Czechia

Countries

Czechia

References

Vosmik M, John S, Dvorak J, Mohelnikova-Duchonova B, Melichar B, Lohynska R, Ryska A, Banni AM, Krempova J, Sirak I. Stereotactic Radiotherapy Plus Nivolumab in Patients with Locally Advanced Pancreatic Cancer: Results from Phase 1/2 Clinical CA209-9KH Trial. Oncol Ther. 2024 Dec;12(4):817-831. doi: 10.1007/s40487-024-00309-z. Epub 2024 Oct 23.

Reference Type: DERIVED

PMID: 39441483 (View on PubMed)

Other Identifiers

CA209- 9KH

Identifier Type: -

Identifier Source: org_study_id