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.
- Drug: MEDI4736 in combination with nab-paclitaxel and gemcitabine
- Drug: MEDI4736 in combination with AZD5069
Phase 1/Phase 2
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
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
Ages Eligible for Study
18 Years - 130 Years
Genders Eligible for Study