ONO-4538 Phase II Rollover Study (ONO-4538-98)
ConditionPan-tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorOno Pharmaceutical Co., Ltd.
About this trial
This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials
Participant who is eligible for ONO-4538 monotherapy or in combination with other therapies as per the clinical trials, and/or investigator-assessed clinical benefit
Disqualifiers
Participant judged to be incapable of providing consent for reasons such as concurrent dementia
Participant judged by the investigator to be inappropriate as participants of this study
Trial design
Design model
Parallel
Treatments tested in this trial
ONO-4538
DrugIV infusion over 30 minutes
oxaliplatin
DrugIV infusion over 2 hours
S-1
DrugAdministered orally twice daily
capecitabine
DrugAdministered orally twice daily
bevacizumab
DrugIV infusion over 30 minutes
temozolomide
DrugAdministered orally once daily for 5 days every 28 days
Treatment groups
59 Participants
are divided into 2 treatment groupsGroup A: ONO-4538 Monotherapy cohortExperimental treatment 1 intervention
Group B: Combination therapy cohortExperimental treatment 6 interventions
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events (Aes)
(non)
Time frame
From Day 1 up to 28 days after the end of the treatment phaseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov