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

Trial ID or NCT#

NCT02583477

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

A Phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different Combinations in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Ages Eligible for Study: 18 to 130
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen or treatment-naïve patients2. Eastern Cooperative Oncology Group 0 or 13. 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 measurements4. 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.
  2. 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.
    1. Exclusion Criteria:
  3. 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 kg5. History of leptomeningeal carcinomatosis6. Ascites requiring intervention7. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy8. Current or prior use of immunosuppressive medication within 14 days of first dose9. 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 treatment11. Uncontrolled intercurrent illness12. Other malignancy within 5 years except for noninvasive malignancies13. Mean QT interval ≥470 ms14. Active infection15. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP16. Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not employing an effective method of birth control17. Prior exposure to immune-mediated therapy18. Known allergy or hypersensitivity to IP formulations or to other human monoclonal antibodies
Exclusion Criteria:
  1. 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 kg5. History of leptomeningeal carcinomatosis6. Ascites requiring intervention7. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy8. Current or prior use of immunosuppressive medication within 14 days of first dose9. 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 treatment11. Uncontrolled intercurrent illness12. Other malignancy within 5 years except for noninvasive malignancies13. Mean QT interval ≥470 ms14. Active infection15. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP16. Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not employing an effective method of birth control17. Prior exposure to immune-mediated therapy18. Known allergy or hypersensitivity to IP formulations or to other human monoclonal antibodies
View All Criteria
Show Less

View on ClinicalTrials.gov