Chemotherapy Combination for Pancreatic Cancer

Recruiting at 26 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Canadian Cancer Trials Group

Must not be taking: Immunosuppressants, PD1 inhibitors

Disqualifiers: Other malignancies, Autoimmune disorders, Cardiac dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: Until progression or unacceptable toxicity

180 Participants Needed

Trial Summary

What is the purpose of this trial?

The standard or usual treatment for this disease consists of two chemotherapy drugs gemcitabine and nab-paclitaxel given together.

Research Team

Derek Jonker

Principal Investigator

Ottawa Hospital Research Institute, ON Canada

Eligibility Criteria

This trial is for adults with metastatic pancreatic ductal adenocarcinoma who haven't had treatment for their advanced disease. They must have measurable disease, be in good health otherwise, and not have used certain drugs before. Participants need to provide tissue and blood samples, complete quality of life questionnaires, use effective contraception if childbearing potential exists, and be able to follow the trial procedures.

Inclusion Criteria

Must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).

Patient must consent to provision of, and investigator(s) must confirm access to and agree to submit within 4 weeks of randomization to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue of adequate amount and quality in order that the specific correlative marker assays proscribed in the protocol may be conducted.

Patient must consent to provision of samples of blood, serum and plasma in order that the specific correlative marker assays proscribed may be conducted.

Exclusion Criteria

active bleeding diatheses;

Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA4, including tremelimumab.

Patients with alopecia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Gemcitabine and Nab-Paclitaxel, with or without Durvalumab and Tremelimumab, until progression or unacceptable toxicity

Until progression or unacceptable toxicity

Days 1, 8, 15 every 28 days

Follow-up

Participants are monitored for overall survival and progression-free survival

35 months

Treatment Details

Interventions

• Durvalumab
• Gemcitabine
• Nab-paclitaxel
• Tremelimumab

Trial Overview The study compares standard chemotherapy (gemcitabine and nab-paclitaxel) against a combination that adds two immunotherapy drugs (durvalumab and tremelimumab). The goal is to see if adding these immune-targeting drugs can better treat this type of cancer compared to the usual approach.

Participant Groups

Group I: Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab Experimental Treatment 4 Interventions

Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Day 1, 8, 15 Q28 days. plus Durvalumab 1500mg IV day 1 only Q28 days; and Tremelimumab 75 mg IV Days 1 cycles 1, 2, 3 and 4 only until unequivocal progression or unacceptable toxicity.

Group II: Gemcitabine plus Nab-Paclitaxel Active Control 2 Interventions

Gemcitabine 1000 mg/m2 IV \& Nab-Paclitaxel 125 mg/m2 until unequivocal progression or unacceptable toxicity. Days 1, 8, 15 Q28 days.

Durvalumab is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as Imfinzi for:

• Locally advanced, unresectable non-small cell lung cancer (NSCLC)

Approved in United States as Imfinzi for:

• Extensive-stage small cell lung cancer (ES-SCLC)
• Limited-stage small cell lung cancer (LS-SCLC)
• Locally advanced or metastatic urothelial carcinoma

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology