Phase 2 study in pretreated patients with advanced pancreatic cancer to assess efficacy of ipilimumab, nivolumab and tocilizumab in combination with radiation. - TRIPPLE-R

Department of Oncology, Herlev & Gentofte Hospital0 sites30 target enrollmentDecember 19, 2019

ConditionsPretreated patients with advanced pancreatic cancer.MedDRA version: 21.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864 MedDRA version: 21.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864 MedDRA version: 21.0Level: LLTClassification code 10033607Term: Pancreatic cancer recurrentSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsOpdivo Yervoy RoActemra

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Pretreated patients with advanced pancreatic cancer.
Sponsor: Department of Oncology, Herlev & Gentofte Hospital
Enrollment: 30
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 19, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Department of Oncology, Herlev & Gentofte Hospital

Eligibility Criteria

Inclusion Criteria

•Signed informed consent:
•\- Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care
•\- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
•Histological or cytological confirmation of locally advanced or metastatic pancreatic carcinoma prior to entering this study
•Prior therapy requirements:
•o For Part A : there is no upper limit on the number of prior chemotherapy regimens received. Patients must have received and progressed during or after at least 1 line of systemic chemotherapy in the metastatic setting (gemcitabine or 5\-FU based regimens).
•\- If a participant received adjuvant/neoadjuvant systemic combinational therapy, and progressed within 6 months, the adjuvant/neoadjuvant treatment will be considered as 1 line of systemic treatment.
•\- In general, discontinuation of 1 drug in a multi\-drug regimen and continuation of other drug(s), is considered part of the same line of treatment. Restarting the same regimen after a drug holiday or maintenance chemotherapy can also be considered part of the same line of treatment. Switching from IV (5\-FU) to an oral formulation (capecitabine) of the same drug is also considered part of the same line of treatment
•\-Minimum time from first systemic therapy for recurrent/metastatic adenocarcinoma of pancreas to progression should be at least 3 months
•Age 18 years and older

Exclusion Criteria

•Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
•Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
•Current or prior use of immunosuppressive medication within 14 days before the first dose of ipilimumab, nivolumab and tocilizumab. The following are exceptions to this criterion:
•\- Intranasal, inhaled, or topical steroids; or local steroid injections (e.g. intra\-articular injection)
•\- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
•\- Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)
•Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
•Allergies and Adverse Drug Reaction:
•\- History of allergy to study drug components
•\- History of severe hypersensitivity reaction to any monoclonal antibody