PHASE I STUDY ELIGIBILITY CRITERIA:\r\nAbility of subject to understand and the willingness to record twice-daily blood pressure readings if the patient is enrolled to the MEDI+C arm or MEDI+O+C arm
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nMajor surgical procedure (as defined by the investigator) within 30 days prior to the first dose of MEDI4736 or still recovering from prior surgery
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): MEDI+O and MEDI+C: Patients must have histologically or cytologically confirmed persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer who are either platinum-sensitive, platinum resistant or refractory during or after a first platinum containing regimen; for platinum-sensitive recurrent disease, the patients must have received at least two prior regimens prior to study enrollment
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): MEDI+O+C: Patients must have histologically or cytologically confirmed persistent or recurrent non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are either platinum-sensitive, platinum resistant or refractory during or after a first platinum containing regimen; for platinum-sensitive recurrent serous epithelial ovarian cancer, the patients must have received at least two prior regimens prior to study enrollment
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Patients must have measurable disease as defined by RECIST v1.1
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): ECOG performance status =< 2
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Absolute neutrophil count >= 1,500/mcL
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): White blood cell (WBC) >= 3,000/mcL
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Platelets >= 100,000/mcL
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Hemoglobin (Hgb) >= 9 g/dL in the absence of packed red blood cell transfusion 28 days prior to dosing
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal (ULN); for subjects with liver metastases, AST or ALT =< 5 X ULN
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Total bilirubin =< 1.5 X ULN; for subjects with documented/suspected Gilbert's disease, bilirubin =< 3 X ULN
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Creatinine =< 1.5 X within normal institutional limits OR measured creatinine clearance >= 50 mL/min/1.73 m^2
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): For OvCa MEDI+C and MEDI+O+C arms only: \r\nSpot urine protein/creatinine ratio =< 1 OR 24 hour urine protein =< 1000 mg
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Patients are allowed to have received prior PARP inhibitors (PARPi), and/or anti-angiogenesis therapy including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics; however, patients who were treated with both olaparib and cediranib, either in combination or sequentially are not eligible; for this study, BSI-201 (iniparib) is not considered as PARPi
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Adequately controlled blood pressure (SBP < 140 mmHg and DBP < 90 mmHg) on a maximum of three anti-hypertensive medications
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v 4.03 except hemoglobin; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the PI
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): \r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluations
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C): Ability of subject to understand and the willingness to record twice-daily blood pressure readings if the patient is enrolled to the MEDI+C or MEDI+O+C arm
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients who have received chemotherapy, radiotherapy, any other investigational agents within 3 weeks (4 weeks for platinum agents and 6 weeks for nitrosoureas or mitomycin) prior to study enrollment
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients who were treated with both olaparib and cediranib, either in combination or sequentially
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapy
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nMajor surgical procedure (as defined by the investigator) within 30 days prior to the first dose of MEDI4736 or still recovering from prior surgery
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients with any other concomitant or prior invasive malignancies are ineligible; however, patients with prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible; patients with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib, cediranib, or to other humanized monoclonal antibodies; known history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthma
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHistory of cerebrovascular accident, transient ischemic attack within 1 year prior to study enrollment
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHistory of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nSignificant hemorrhage (> 30 mL bleeding/episode within 3 months before study enrollment) or haemoptysis (> 5 mL fresh blood within 28 days before study enrollment)
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nCurrent signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 28 days before study enrollment
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nCurrent dependency on TPN or IV fluid hydration
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nUncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (except chronic atrial fibrillation with controlled vascular rate), active peptic ulcer disease, or psychiatric illness/social situations that would limit compliance with study requirements
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPregnant and breastfeeding women are excluded from this study
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHIV-positive patients on antiretroviral therapy are ineligible; however, patients with long-standing (> 5 years) HIV on antiretroviral therapy > 1 month (undetectable HIV viral load and CD4 count > 150 cells/uL) may be eligible if the PI determines no anticipated clinically significant drug-drug interactions
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nHBV- or HCV-positive patients are ineligible
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nKnown history of previous clinical diagnosis of tuberculosis
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nNo baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicated
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nNo prior or current evidence of coagulopathy or bleeding diathesis; therapeutic anti-coagulation for prior thromboembolic events is permitted
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nConcurrent enrollment in another clinical study, unless it is an observational noninterventional clinical study or the follow-up of an interventional study
PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nAny concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment; concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable; NOTE: Local treatment of isolated lesions for palliative intent is acceptable (e.g., by local surgery or radiotherapy)
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY)\r\nPatients must have measurable disease as defined by RECIST v1.1
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nECOG performance status =< 2
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAbsolute neutrophil count >= 1,500/mcL
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nWhite blood cell (WBC) >= 3,000/mcL
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPlatelets >= 100,000/mcL
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nTotal bilirubin =< 1.5 × ULN; for subjects with documented/suspected Gilbert’s disease, bilirubin =< 3 × ULN
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nCreatinine =< 1.5 X within normal institutional limits OR measured creatinine clearance >= 50 mL/min/1.73 m^2
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nToxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v 4.03 except hemoglobin; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the PI
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluations
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have received prior PARP inhibitors (PARPi) are ineligible; for this study, BSI-201 (iniparib) is not considered as PARPi
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapy
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nMajor surgical procedure (as defined by the investigator) within 30 days prior to the first dose of MEDI4736 or still recovering from prior surgery
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib or to other humanized monoclonal antibodies; known history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthma
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHistory of cerebrovascular accident, transient ischemic attack within 1 year prior to study enrollment
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nSignificant hemorrhage (> 30 mL bleeding/episode within 3 months before study enrollment) or haemoptysis (> 5 mL fresh blood within 28 days before study enrollment)
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nCurrent dependency on TPN or IV fluid hydration
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPregnant and breastfeeding women are excluded from this study
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHBV or HCV-positive patients are ineligible
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nKnown history of previous clinical diagnosis of tuberculosis
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nNo baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicated
PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nNo prior or current evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nMust have metastatic, progressive, castrate resistant prostate cancer (mCRPC)
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAll patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients must have undergone bilateral surgical castration or must agree to continue on gonadotropin releasing hormone (GnRH) agonists/antagonists for the duration of the study
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nECOG performance status =< 2
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nAbsolute neutrophil count >= 1,500/mcL
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nWhite blood cell (WBC) >= 3,000/mcL
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPlatelets >= 100,000/mcL
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nTotal bilirubin =< 1.5 X ULN; for subjects with documented or suspected Gilbert’s disease, bilirubin =< 3 X ULN
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nCreatinine =< 1.5 X within normal institutional limits OR measured creatinine clearance >= 50 mL/min/1.73 m^2
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatient must be capable of understanding and complying with protocol requirements and is willing to give informed consent
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have had prior treatment with olaparib or other PARP inhibitors
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapy
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nThe patient has received any other type of investigational agent within 28 days before the first dose of study treatment
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nThe patient has received radionuclide treatment within 6 weeks prior to the first dose of the study treatment
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nThe patient is unable to swallow tablets or capsules
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHistory of allergic reactions (known history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthma) attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib, or to other humanized monoclonal antibodies
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nHBV-or HCV-positive patients are ineligible
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nPatients are allowed to have received prior anti-angiogenesis therapy with the exception of prior cediranib
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nPatients must have at least one focus of metastatic disease that is amenable to pre- and on-treatment biopsy
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nAll patients must have measurable disease
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nECOG performance status =< 2
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nAbsolute neutrophil count >= 1,500/mcL
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nWhite blood cell (WBC) >= 3,000/mcL
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nPlatelets >= 100,000/mcL
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nCreatinine =< 1.5 X within normal institutional limits OR measured creatinine clearance >= 50 mL/min/1.73 m^2
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nAbility of subject to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluations
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nAbility of subject to understand and the willingness to record twice-daily blood pressure readings
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nPatients who were previously treated with cediranib
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nPatients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapy
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nMajor surgical procedure (as defined by the investigator) within 30 days prior to the first dose of MEDI4736 or still recovering from prior surgery
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI4736, cediranib, or to other humanized monoclonal antibodies; known history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthma
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nHistory of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nPatients with prior history of pneumonitis and/or interstitial lung disease will be excluded
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nReceipt of live attenuated vaccination within 30 days before the first dose of MEDI4736
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nSignificant hemorrhage (> 30 mL bleeding/episode within 3 months before study enrollment) or hemoptysis (> 5mL fresh blood within 28 days before study enrollment)
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nPregnant and breastfeeding women are excluded from this study
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nHBV-or HCV-positive patients are ineligible
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nKnown history of previous clinical diagnosis of tuberculosis
PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nNo prior or current evidence of coagulopathy or bleeding diathesis; therapeutic anti-coagulation for prior thromboembolic events is permitted
Subjects must not donate blood while on study and for at least 90 days following the last MEDI4736 treatment.