InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 28 March 2024

D6070C00005: This phase I/II trial is evaluating two immunotherapy drugs (MEDI9447 and durvalumab) given alone or in combination, with chemotherapy, in patients with pancreatic cancer that has spread to other parts of the bodyA Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) With or Without Durvalumab in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma

Clinical summary

Summary

Participants in this trial will be randomised into one of 6 Arms of treatment, across two distinct cohorts. In cohort A, patients must have previously untreated metastatic pancreatic cancer (1st line metastatic disease). In Cohort B, patients with metastatic pancreatic cancer may have been previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2nd line metastatic disease. Two Arms across Cohort A and B (Arm A1 and Arm B1) will act as a comparators to the trial treatment, in which participants will either receive gemcitabine and nab-paclitaxel or mFOLFOX chemotherapy. In Arm A2 participants will receive gemcitabine and nab-paclitaxel plus MEDI9447, and in Arm A3 participants will also receive durvalumab on top of the Arm A2 treatment. In Arm B2 participants will receive mFOLXFOX chemotherapy plus MEDI9447, and in Arm B3 participants will also receive durvalumab on top of the Arm B2 treatment. All treatment will be given until disease progression.

Conditions

This trial is treating patients with pancreatic cancer.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18 - 101

Phase

I/II

Trial Acronym

D6070C00005

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

MedImmune, LLC

Scientific Title

A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) With or Without Durvalumab in Combination With Chemotherapy in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility

Inclusion

  1. Age >= 18
  2. Written and signed informed consent must be obtained
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  4. Weight >= 35 kg

  5. Participants must have histologically or cytologically, confirmed pancreatic adenocarcinoma:

    Cohort A: Participants with previously untreated metastatic pancreatic adenocarcinoma (1L metastatic disease) not previously treated with systemic therapies Cohort B: Participants with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2L metastatic disease

  6. Participants must have at least 1 measurable lesion according to RECIST v1.1
  7. All Participants must consent to providing archival tumor specimens.

Exclusion

  1. Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment.
  2. Prior receipt of any immune-related therapy
  3. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed.
  4. Participants with a history of venous thrombosis within the past 3 months
  5. Participants with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 3 months prior to start of treatment
  6. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
  7. Other invasive malignancy within 2 years
  8. Any history of leptomeningeal disease or cord compression
  9. Current or prior use of immunosuppressive medication within 14 days prior to the first dose.

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

Submitting ... Please wait

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.