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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03555149
Other study ID # CO39612
Secondary ID 2017-004566-99
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date September 27, 2018
Est. completion date September 26, 2022

Study information

Verified date November 2023
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms.


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Study Design


Related Conditions & MeSH terms


Intervention

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Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  France,  Korea, Republic of,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Best Confirmed Overall Response Rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 The best confirmed overall response rate (ORR) is defined as the percentage of participants with a complete response or partial response on two consecutive occasions =4 weeks apart, as determined by the investigator according to RECIST v1.1. Participants could be classified as "Stable Disease" if the assessment was at least 6 weeks from randomization. Participants were classified as Missing if no post-baseline response assessments were available. Participants were classified as Not Evaluable if all post-baseline response assessments were unevaluable. The differences in ORR between the experimental arms and the corresponding control arm were calculated, along with 95% confidence intervals (CIs), using normal approximation of the binomial distribution. The 95% CIs for ORRs were constructed using the Clopper-Pearson method. The 95% CIs for the difference in rates were constructed using the Wald method with continuity correction. From randomization until disease progression or loss of clinical benefit (up to 4 years)
Secondary Progression-Free Survival (PFS) as Determined by Investigator According to RECIST v1.1 Progression-free survival (PFS) after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), was determined by the investigator according to RECIST v1.1. For participants who did not have documented disease progression or death, PFS was censored at the day of the last tumor assessment. The Kaplan-Meier method was used to estimate the median for PFS with 95% confidence intervals (CIs) constructed through use of the Brookmeyer and Crowley method. From randomization up to the first occurrence of disease or death from any cause (up to 4 years)
Secondary Overall Survival (OS) Overall survival (OS) is defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier method was used to estimate the median for OS with 95% confidence intervals (CIs) constructed through use of the Brookmeyer and Crowley method. From randomization up to death from any cause (up to 4 years)
Secondary Percentage of Participants Who Were Alive at Landmark Timepoints for Overall Survival (OS) Overall survival (OS) is defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. OS is shown as the percentage of participants who were event-free at the landmark timepoints of 3, 6, 12, and 18 months. 3, 6, 12, and 18 months
Secondary Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 Duration of response is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause. From the date of first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 4 years)
Secondary Disease Control Rate (DCR), as Determined by the Investigator Per RECIST v1.1 Disease control rate is defined as the percentage of participants with stable disease for =12 weeks or a complete or partial response, as determined by the investigator according to RECIST v1.1. From randomization until disease progression or loss of clinical benefit (up to 4 years)
Secondary Percentage of Participants With at Least One Adverse Event (AE) The incidence, nature, and severity of adverse events (AEs) are reported, with severity determined according to NCI CTCAE v4.0. All AEs were reported until 30 days after the last study dose or until start of new systemic anti-cancer therapy. Serious AEs and AEs of special interest were reported until 135 days (or 180 days for the Atezolizumab + LOAd703 arm only) after the last dose of study treatment. Adverse event data were collected from baseline up to 6 months after the last dose of study treatment (up to 640 days); deaths (all-cause) were reported from baseline through survival follow-up (up to 4 years)
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