Trial Search Results

Phase Ib/II Study of MEDI4736 Evaluated in Different Combinations in Metastatic Pancreatic Ductal Carcinoma

A Phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different Combinations (with chemotherapy or AZD5069) in Patients with Metastatic Pancreatic Ductal Adenocarcinoma

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AstraZeneca

Stanford Investigator(s):

Intervention(s):

  • Drug: MEDI4736 in combination with nab-paclitaxel and gemcitabine
  • Drug: MEDI4736 in combination with AZD5069

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   1. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior
   chemotherapy regimen or treatment-naïve patients

   2. Eastern Cooperative Oncology Group 0 or 1

   3. At least 1 lesion, not previously irradiated, that can be accurately measured at
   baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short
   axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) scan
   and that is suitable for accurate repeated measurements

   4. MEDI4736 + nab-paclitaxel + gemcitabine chemotherapy cohort: treatment-naïve patients
   with metastatic PDAC who have received no previous systemic chemotherapy 5 MEDI4736 +
   Cohort: Patient should receive no more than 1 prior systemic chemotherapy regimen.

6. Life expectancy ≥ 12 weeks. 7. ECOG PS of 0 or 1 8. Adequate organ and bone marrow
function 9. Ability to undergo during screening a tumor biopsy that is adequate for
biomarker analysis.

Exclusion Criteria:

   1. Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy
   for cancer treatment.

   2. Receipt of any investigational anticancer therapy within 28 days or 5 half-lives,
   whichever is shorter, prior to the first dose of study treatment.

   3. Major surgical procedure within 21 days prior to the first dose of IP.

   4. Patients weighing less than 30 kg

   5. History of leptomeningeal carcinomatosis

   6. Ascites requiring intervention

   7. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy

   8. Current or prior use of immunosuppressive medication within 14 days of first dose

   9. Brain metastases or spinal cord compression.

10. Medi4736+AZD5069 Cohort only: received any potent and moderate cytochrome CYP3A4
   inhibitors, potent and moderate CYP3A4 inducers, P-gp substrates, BCRP substrates,
   sensitive CYP2B6 substrates, warfarin and coumarin derivatives, or herbal supplements
   within 14 days of the first dose of study treatment

11. Uncontrolled intercurrent illness

12. Other malignancy within 5 years except for noninvasive malignancies

13. Mean QT interval ≥470 ms

14. Active infection

15. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP

16. Female patients who are pregnant or breastfeeding, or male or female patients of
   reproductive potential who are not employing an effective method of birth control

17. Prior exposure to immune-mediated therapy

18. Known allergy or hypersensitivity to IP formulations or to other human monoclonal
   antibodies

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting