A Phase 1/2 Study to Evaluate MEDI4736

NCT01693562 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CD-ON-MEDI4736-1108
• Study Type: interventional
• Target: 1,022
• Locations: 9 countries
• Sites: 79

Brief Summary

This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in participants with advanced solid tumors followed by an expansion phase in participants with advanced solid tumors. An exploration cohort has been added to determine the safety using every 4 weeks (Q4W) dosing.

Conditions

Advanced Solid Tumors

Keywords

Advanced solid tumors

Outcome Measures

Primary Outcomes (8)

• Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase

  A DLT was defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT-evaluation period including any \>= Grade 3 colitis or \>= Grade 3 immune-related adverse event (irAE; AEs of immune nature in the absence of a clear alternative etiology) including rash, pruritus, or diarrhea that did not downgrade to =\< Grade 2 within 3 days after onset of the event despite maximal supportive care including systemic corticosteroids. The DLT-evaluation period for 0.1 to 10 mg/kg arms was from Day 1 to Day 28 of first dose and for 15 mg/kg arm was from Day 1 to Day 42 of first dose.

  For MEDI4736 0.1 to MEDI4736 10 mg/kg arms: from Day 1 to Day 28 of first dose; for MEDI4736 15 mg/kg arm: from Day 1 to Day 42 of first dose

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

  An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

  From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

• Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

  Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of coagulation, urine, hematology, and serum chemistry.

  From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

• Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

  Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body weight, body temperature, blood pressure, pulse rate, and respiratory rate).

  From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

• Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

  Number of participants with change from baseline in notable QT/QTc interval in local electrocardiogram (ECG) are reported. The data for \>0 participants with notable QT/QTc interval in local ECG from baseline are reported.

  From Baseline (Day 1) through 90 days after the last dose of study drug (approximately 5.25 years)

• Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) in Participants With Non-squamous NSCLC Who Had Received 2 or More Prior Lines of Therapy in the Dose-expansion Phase

  The ORR assessed by BICR in participants with non-squamous NSCLC who had received 2 or more prior lines of therapy is reported. The ORR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between.

  From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

• ORR Assessed by BICR in Participants With Squamous NSCLC Who Had Received 1 and 2 or More Prior Lines of Therapy in the Dose-expansion Phase

  The ORR assessed by BICR in participants with squamous NSCLC who had received 1 and 2 or more prior lines of therapy is reported. The ORR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between.

  From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

• ORR Assessed by BICR in Participants With UC Post-platinum (Programmed Cell Death Ligand [PD-L1] Status High) Who Had Received at Least 1 Line of Prior Therapy (2L+) in the Dose-expansion Phase

  The ORR assessed by BICR in participants with UC post-platinum PD-L1 status high 2L+ is reported. The ORR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between.

  From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Secondary Outcomes (24)

• Area Under the Serum Concentration-time Curve up to the Last Measurable Concentration (AUClast) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase

  After the first dose between Day 0 and Day 15 (Day 1 [pre and post dose] and predose of Dose 2 for all cohorts; Days 3, 5, 10 for Cohorts 0.1mg/kg to 10 mg/kg; Days 3, 5, 10, 15 for Cohort 15 mg/kg; Day 15 for Cohort 20 mg/kg)

• Maximum Serum Concentration (Cmax) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase

  After the first dose between Day 0 and Day 15 (Day 1 [pre and post dose] and predose of Dose 2 for all cohorts; Days 3, 5, 10 for Cohorts 0.1mg/kg to 10 mg/kg; Days 3, 5, 10, 15 for Cohort 15 mg/kg; Day 15 for Cohort 20 mg/kg)

• Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI4736 in the Dose-escalation, Dose-exploration Phase, and Dose-expansion Phase.

  Escalation: Day1 of Dose(D)1 & D3, even numbered doses after D4; Exploration: Day1 of D1 & D2, even numbered doses after D2; Expansion: Day1 of D1, every 12 weeks since D3; all phases: till EOT, 30 days and 3 and 6 months post last dose (~5.25 years)

• Number of Participants With Best Overall Response (BOR) Assessed by BICR in NSCLC and SCCHN Cohort in the Dose-expansion Phase

  From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

• Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

  From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Study Arms (23)

Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)

EXPERIMENTAL

Participants will receive intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)

EXPERIMENTAL

Participants will receive IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Escalation Cohort (MEDI4736 1 mg/kg Q2W)

EXPERIMENTAL

Participants will receive IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Escalation Cohort (MEDI4736 3 mg/kg Q2W)

EXPERIMENTAL

Participants will receive IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Escalation Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Escalation Cohort (MEDI4736 15 mg/kg Q3W)

EXPERIMENTAL

Participants will receive IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Exploration Durvalumab 20 mg/kg (Q4W)

EXPERIMENTAL

Participants will receive IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with squamous cell carcinoma of the head and neck (SCCHN) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion Non-SCCHN Cohort HPV positive (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with non-small-cell lung cancer (NSCLC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with hepatocellular carcinoma (HCC Total) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with advance cutaneous melanoma (ACM) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with uveal melanoma (UM) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with gastroesophageal cancer (GEC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with triple-negative breast cancer (TNBC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with pancreatic adenocarcinoma (PAC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with urothelial carcinoma (UC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with glioblastoma multiforme (GBM) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with ovarian cancer (OC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with soft- tissue sarcoma (STS) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with small-cell lung cancer (SCLC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with microsatellite instability (MSI)-high cancer will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)

EXPERIMENTAL

Participants with nasopharyngeal carcinoma (NPC) will receive IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Drug: MEDI4736

Interventions

MEDI4736 DRUG

Participants will receive IV infusion of MEDI4736 for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Also known as: Durvalumab

Escalation Cohort (MEDI4736 0.1 mg/kg Q2W); Escalation Cohort (MEDI4736 0.3 mg/kg Q2W); Escalation Cohort (MEDI4736 1 mg/kg Q2W); Escalation Cohort (MEDI4736 10 mg/kg Q2W); Escalation Cohort (MEDI4736 15 mg/kg Q3W); Escalation Cohort (MEDI4736 3 mg/kg Q2W); Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W); Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W); Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W); Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W); Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W); Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W); Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W); Expansion Non-SCCHN Cohort HPV positive (MEDI4736 10 mg/kg Q2W); Expansion OC Cohort (MEDI4736 10 mg/kg Q2W); Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W); Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W); Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W); Expansion STS Cohort (MEDI4736 10 mg/kg Q2W); Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W); Expansion UC Cohort (MEDI4736 10 mg/kg Q2W); Expansion UM Cohort (MEDI4736 10 mg/kg Q2W); Exploration Durvalumab 20 mg/kg (Q4W)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older.
• In the dose-escalation phase: histologically- or cytologically- confirmed advanced solid tumor that is refractory to standard therapy and for which no standard therapy exists.
• In the dose-expansion phase: histologically- or cytologically- confirmed advanced solid tumor where if an approved first-line therapy is available, participants must have failed, be intolerant to, be ineligible for, or have refused
• Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
• Adequate organ and marrow function.
• Participants must have at least 1 measurable lesion.
• Available archived tumor tissue sample.
• Willingness to provide consent for biopsy sample (dose-expansion only)

You may not qualify if:

• Any prior Grade ≥ 3 immune-mediated adverse event (imAE) while receiving immunotherapy
• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
• Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
• Prior treatment with immunotherapy agents including, but not limited to, tumor necrosis factor receptor superfamily agonists or checkpoint inhibitors or natural killer (NK) cell inhibitors.
• Active or prior documented autoimmune disease within the past 2 years
• History of primary immunodeficiency
• History of organ transplant that requires use of immunosuppressives
• Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent treatment
• Other invasive malignancy within 2 years
• Women who are pregnant or lactating
• Uncontrolled intercurrent illness
• Known history of tuberculosis
• Known to be human immunodeficiency virus (HIV) positive
• Known to be Hepatitis B or C positive (except HCC participants)

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (79)

Research Site

Scottsdale, Arizona, 85258, United States

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Burbank, California, 91505, United States

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Gilroy, California, 95020, United States

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Los Angeles, California, 90025, United States

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Los Angeles, California, 90095, United States

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Orange, California, 92868, United States

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Palo Alto, California, 94304-5826, United States

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San Francisco, California, 94115, United States

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Whittier, California, 90603, United States

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New Haven, Connecticut, 06520, United States

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Washington D.C., District of Columbia, 20007, United States

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Jacksonville, Florida, 32224, United States

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Miami Beach, Florida, 33140, United States

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Tampa, Florida, 33612, United States

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Athens, Georgia, 30607, United States

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Augusta, Georgia, 30912, United States

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Chicago, Illinois, 60637, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21231, United States

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Boston, Massachusetts, 02215, United States

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Ann Arbor, Michigan, 48109, United States

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Detroit, Michigan, 48201, United States

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Minneapolis, Minnesota, 55407, United States

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Saint Louis Park, Minnesota, 55416, United States

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Billings, Montana, 59101, United States

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Las Vegas, Nevada, 89169, United States

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Hackensack, New Jersey, 07601, United States

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Paterson, New Jersey, 07503, United States

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New York, New York, 10065, United States

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The Bronx, New York, 10461, United States

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Chapel Hill, North Carolina, 27599, United States

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Huntersville, North Carolina, 28078, United States

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Cleveland, Ohio, 44106, United States

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Columbus, Ohio, 43210, United States

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Portland, Oregon, 97213, United States

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Philadelphia, Pennsylvania, 19107-5097, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Greenville, South Carolina, 29605, United States

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Nashville, Tennessee, 37203, United States

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Dallas, Texas, 75201, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77090, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84403, United States

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Blacksburg, Virginia, 24060, United States

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Fairfax, Virginia, 22031, United States

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Seattle, Washington, 98104, United States

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, B-4000, Belgium

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Namur, 5000, Belgium

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H2X 3E4, Canada

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Paris, 75475, France

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Villejuif, 94800, France

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Berlin, 12200, Germany

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Gauting, 82131, Germany

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Heidelberg, 69120, Germany

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Jena, 07747, Germany

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Minden, 32429, Germany

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Lecce, 73100, Italy

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Milan, 20141, Italy

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Milan, 20132, Italy

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Napoli, 80131, Italy

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Siena, 53100, Italy

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Gwangju, 61469, South Korea

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Seogu, 49241, South Korea

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Seongnam-si, 13620, South Korea

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Seoul, 03080, South Korea

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Seoul, 05505, South Korea

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Seoul, 06351, South Korea

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Tainan, 70403, Taiwan

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Taipei, 10002, Taiwan

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London, EC1A 7BE, United Kingdom

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London, SW2 6JJ, United Kingdom

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London, W1G 6AD, United Kingdom

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Oxford, OX3 7LE, United Kingdom

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Sutton, SM2 5PT, United Kingdom

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Related Publications (13)

• Li Q, Cristini V, Gupta A, Achour I, Barrett JC, Koay EJ. Clinical Validation of Mathematically Derived Early Tumor Dynamics for Solid Tumors in Response to Durvalumab. JCO Clin Cancer Inform. 2024 Jul;8:e2300254. doi: 10.1200/CCI.23.00254.

  PMID: 38996196 DERIVED

• Gavrilov S, Zhudenkov K, Helmlinger G, Dunyak J, Peskov K, Aksenov S. Longitudinal Tumor Size and Neutrophil-to-Lymphocyte Ratio Are Prognostic Biomarkers for Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Treated With Durvalumab. CPT Pharmacometrics Syst Pharmacol. 2021 Jan;10(1):67-74. doi: 10.1002/psp4.12578. Epub 2020 Dec 21.

  PMID: 33319498 DERIVED

• Sheth S, Gao C, Mueller N, Angra N, Gupta A, Germa C, Martinez P, Soria JC. Durvalumab activity in previously treated patients who stopped durvalumab without disease progression. J Immunother Cancer. 2020 Aug;8(2):e000650. doi: 10.1136/jitc-2020-000650.

  PMID: 32847985 DERIVED

• Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.

  PMID: 32816849 DERIVED

• Zajac M, Ye J, Mukhopadhyay P, Jin X, Ben Y, Antal J, Gupta AK, Rebelatto MC, Williams JA, Walker J. Optimal PD-L1-high cutoff for association with overall survival in patients with urothelial cancer treated with durvalumab monotherapy. PLoS One. 2020 Apr 27;15(4):e0231936. doi: 10.1371/journal.pone.0231936. eCollection 2020.

  PMID: 32339189 DERIVED

• Nordstrom BL, Oguz M, Chu BC, Ouwens M, Arkenau HT, Klein AB. Effectiveness of durvalumab versus chemotherapy in metastatic urothelial cancer: an observational, indirect comparison. J Comp Eff Res. 2020 Feb;9(3):191-199. doi: 10.2217/cer-2019-0163. Epub 2020 Jan 9.

  PMID: 31916448 DERIVED

• Antonia SJ, Balmanoukian A, Brahmer J, Ou SI, Hellmann MD, Kim SW, Ahn MJ, Kim DW, Gutierrez M, Liu SV, Schoffski P, Jager D, Jamal R, Jerusalem G, Lutzky J, Nemunaitis J, Calabro L, Weiss J, Gadgeel S, Bhosle J, Ascierto PA, Rebelatto MC, Narwal R, Liang M, Xiao F, Antal J, Abdullah S, Angra N, Gupta AK, Khleif SN, Segal NH. Clinical Activity, Tolerability, and Long-Term Follow-Up of Durvalumab in Patients With Advanced NSCLC. J Thorac Oncol. 2019 Oct;14(10):1794-1806. doi: 10.1016/j.jtho.2019.06.010. Epub 2019 Jun 20.

  PMID: 31228626 DERIVED

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Related Links

• CSP amendment
• SAP redacted

MeSH Terms

Interventions

durvalumab

Results Point of Contact

• Title: Ashok Gupta
• Organization: MedImmune, LLC

information.center@astrazeneca.com

+13013981287

Study Officials

• MedImmune, LLC

  MedImmune LLC

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: September 26, 2012
• Study Start: September 5, 2012
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: May 13, 2021
• Results First Posted: May 13, 2021

Record last verified: 2021-04

Locations

TW (2); CA (3); KR (6); DE (5); FR (2); BE (4); GB (5); US (47); IT (5)