ADJUBIL

Frankfurter Institut für Klinische Krebsforschung IKF GmbH

Steinbacher Hohl 2-26, Frankfurt am Main, Germany,

IKF, Frankfurter Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, 0049 6976014420, adjubil@ikf-khnw.de

IKF, Frankfurter Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, 0049 6976014420, adjubil@ikf-khnw.de

No

No

No

Final

06 Aug 2025

No

Yes

20 Feb 2025

No

To assess the anti-tumor activity of the combination of durvalumab and tremelimumab with or without capecitabine by the recurrence-free survival rate after 12 months (RFS@12).

This clinical trial study was designed and shall be implemented and reported in accordance with the protocol, the AMG (Arzneimittelgesetz), the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (including European Directive 2001/20/EC), and with the ethical principles laid down in the Declaration of Helsinki. The trial was authorized/Approved by the competent authority (Paul-Ehrlich-Institut, PEI) and the competent ethics committee responsible for the trial (“federführende Ethikkommission). Before recruitment into the clinical trial, each patient was informed that participation in the study is completely voluntary, and that he or she may withdraw his or her participation in the trial at any time without any declaration of reasons, which will not lead to any disadvantage for the respective patient. The eligibility of a new patient was determined by the local investigator during regular clinical visits. The examinations for the study and the inclusion of the patient were done after detailed written and oral education about aims, methods, anticipated benefits and potential hazards of the study by use of the informed consent forms and after given written consent of the patient. Safety was monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported. An independent safety data monitoring committee (SDMC) was responsible for assessment of reports summarizing safety data or study results and gave recommendations for planned protocol amendments.

16 Feb 2022

No

Yes

Germany: 40

40

40

0

0

0

0

0

0

20

20

0

Overall Period

Randomised - controlled

Yes

Durvalumab

Concentrate and solvent for solution for infusion

Intravenous use

Patients received durvalumab at a fixed dose of 1500 mg as an IV infusion over 1 hour, on day 1 together with the Tremelimumab infusion. Durvalumab only infusion was repeated every 4 weeks for a maximum of 12 months on day 1 of each cycle. An exception to the fixed dosing listed above for durvalumab is made for patients with low body weight (below 30 kg): Patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to 20 mg/kg Q4W, until weight increases to greater than 30 kg.

Tremelimumab

Concentrate and solvent for solution for infusion

Intravenous use

Patients received tremelimumab at a fixed dose of 300 mg as an IV infusion over 1 hour on day 1 of cycle 1.

Capecitabine

Tablet

Oral use

Patient's received capecitabine at 1250 mg/m² p.o. twice a day on days 1 to 14 of a 3-weekly cycle (eight cycles).

Durvalumab

Concentrate and solvent for solution for infusion

Intravenous use

Patients received durvalumab at a fixed dose of 1500 mg as an IV infusion over 1 hour, on day 1 together with the Tremelimumab infusion. Durvalumab only infusion was repeated every 4 weeks for a maximum of 12 months on day 1 of each cycle. An exception to the fixed dosing listed above for durvalumab is made for patients with low body weight (below 30 kg): Patients with a body weight of 30 kg or less must receive weight-based dosing, equivalent to 20 mg/kg Q4W, until weight increases to greater than 30 kg.

Tremelimumab

Concentrate and solvent for solution for infusion

Intravenous use

Patients received tremelimumab at a fixed dose of 300 mg as an IV infusion over 1 hour on day 1 of cycle 1.

Arm A

Arm B

Arm A

Arm B

Recurrence-free survival at 12 months (RFS@12) was defined as the proportion of allocated subjects without any recurrence/progression and alive at 12 months after the date of treatment allocation.

Primary

until 12 months after treatment allocation

Recurrence-free survival (RFS) was determined as time from the date of treatment allocation to the date of any recurrence/progression (local or regional [including invasive ipsilateral tumor and invasive locoregional tumor], or distant) or death due to any cause. Patients without event were censored at the date of their last tumor assessment prior to any subsequent anticancer therapy.

Secondary

from the date of treatment allocation to the date of any recurrence/progression or death due to any cause

Overall survival (OS) will be determined as time from the date of treatment allocation to the date of death due to any cause. A subject who has not died will be censored at last known date alive. Median OS was not reached for Arm B (here displayed as 9999)

Secondary

from the date of treatment allocation to the date of death due to any cause

Adverse events were assessed continuously during the study, starting with randomization and until 90 days after last dose of study treatment.

Listed here are all serious adverse events and the most common non-serious adverse events, which occurred in ≥ 20% of the patients in at least one of both arms. A detailed listing of all non-serious adverse events which occured in ≥ 5% of the patients is attached as pdf file (summary attachment)

5.0

Safety analysis set Arm A

Safety analysis set Arm B