Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase I, open-label, multicentre study of MEDI4736 administered intravenously with a standard 3+3 dose-escalation phase to evaluate safety, tolerability, and pharmacokinetics in patients with advanced solid tumor followed by an expansion phase in patients with advanced solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI4736 Q2W | Experimental | Evaluate MEDI4736 given every 2 weeks |
|
| MEDI4736 Q3W | Experimental | Evaluate MEDI4736 given every 3 weeks |
|
| MEDI4736 Dose Expansion | Experimental | evaluate MEDI4736 given every 2 weeks |
|
| MEDI4736 Q4W | Experimental | Evaluate MEDI4736 given every 4 weeks |
|
| MEDI4736 combined with another drug | Experimental | evaluate MEDI4736 in combination with another drug given every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI4736 | Drug | MEDI4736 will be administered by IV infusion every 14, 21 or 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing dose-limiting toxicities, adverse events (AEs), serious adverse events (SAEs) | Safety profile will be assessed through number of participants experiencing adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, and physical examinations. | 90 days after the last dose of MEDI4736 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration of MEDI4736 time curve | If data allow, noncompartmental PK parameter (AUC) will be estimated. | Up to 90 days after the last dose of MEDI4736 |
| Percentage of participants who developed detectable anti-drug antibodies (ADAs). |
Not provided
Inclusion Criteria:
In the dose-expansion phase: histologically- or cytologically-confirmed advanced or metastatic biliary tract cancer (BTC), esophagus cancer(EC) (squamous cell carcinoma) or squamous cell carcinoma of the head and neck (SCCHN). - men or women. - Eastern Cooperative Oncology Group (ECOG) status of 0 or 1. - Adequate organ and marrow function. - Subjects must have at least 1 measurable lesion. - Available archived tumor tissue sample. - Willingness to provide consent for biopsy samples.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Iannone, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beppu-shi | 874-0011 | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35611499 | Derived | Doki Y, Ueno M, Hsu CH, Oh DY, Park K, Yamamoto N, Ioka T, Hara H, Hayama M, Nii M, Komuro K, Sugimoto M, Tahara M. Tolerability and efficacy of durvalumab, either as monotherapy or in combination with tremelimumab, in patients from Asia with advanced biliary tract, esophageal, or head-and-neck cancer. Cancer Med. 2022 Jul;11(13):2550-2560. doi: 10.1002/cam4.4593. Epub 2022 May 24. |
Not provided
Not provided
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Not provided
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| tremelimumab | Drug | tremelimumab is administered by IV infusion every 4 weeks |
|
The immunogenic potential of MEDI4736 or tremelimumab will be assessed by summarizing the number percentage of subjects who develop detectable anti-drug antibodies (ADAs). |
| Up to 6 months after the last dose of MEDI4736 or up to 1 month after the last dose of tremelimumab where applicable. |
| Objective response rate (ORR) | From first dose of study drug until death or up to 2 years |
| Maximum tolerated dose (MTD) or optimal biological dose (OBD) | maximum tolerated dose (MTD) or optimal biological dose (OBD) of MEDI4736, if possible | 90 days after the last dose of MEDI4736 |
| Maximum concentration of MEDI4736 | If data allow, noncompartmental PK parameter (Cmax) will be estimated. | Up to 90 days after the last dose of MEDI4736 |
| Clearance | If data allow, noncompartmental PK parameter (CL) will be estimated. | Up to 90 days after the last dose of MEDI4736 |
| half-life after administration of MEDI4736 | If data allow, noncompartmental PK parameter (t½) will be estimated. | Up to 90 days after the last dose of MEDI4736 |
| Disease control rate (DCR) | From first dose of study drug until death or up to 2 years |
| Duration of response (DoR) | From first dose of study drug until death or up to 2 years |
| Progression-free survival (PFS) | Alive and progression free at 6 months (APF6) and 12 months (APF12) will be obtained using the Kaplan-Meier plot of PFS. | From first dose of study drug until death or up to 2 years |
| Overall survival (OS) | The proportion of patients alive at 12 months will be obtained from the Kaplan-Meier plot of OS. | From first dose of study drug until death or up to 2 years |
| Chūōku |
| 104-0045 |
| Japan |
| Research Site | Kashiwa | 277-8577 | Japan |
| Research Site | Kitaadachi-gun | 362-0806 | Japan |
| Research Site | Kōtoku | 135-8550 | Japan |
| Research Site | Kure-shi | 737-0023 | Japan |
| Research Site | Matsuyama | 791-0280 | Japan |
| Research Site | Nagoya | 464-8681 | Japan |
| Research Site | Osaka | 541-8567 | Japan |
| Research Site | Sapporo | 003-0804 | Japan |
| Research Site | Sapporo | 060-8648 | Japan |
| Research Site | Sayama | 589-8511 | Japan |
| Research Site | Suita-shi | 565-0871 | Japan |
| Research Site | Sunto-gun | 411-8777 | Japan |
| Research Site | Takatsuki-shi | 569-8686 | Japan |
| Research Site | Yokohama | 241-8515 | Japan |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 135-710 | South Korea |
| Research Site | Tainan | 704 | Taiwan |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D004067 | Digestive System Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| C520704 | tremelimumab |
Not provided
Not provided
Not provided