Trial · NCT03386721
Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors
NCT03386721, Phase 2, Terminated, Hoffmann-La Roche; results first posted 2023-02-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors. Trials, record NCT03386721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03386721
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors
- NCT number
- NCT03386721
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 256 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers
- Interventions
- simlukafusp alfa, Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody, Gemcitabine, Vinorelbine
- First posted
- 2017-12-29
- Last updated
- 2023-02-21
- Other registries' IDs
- eudract:2017-003182-94
- Results first posted
- 2023-02-21
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Baseline up to disease progression or study treatment discontinuation (up to 38 months) | ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point. |
| Secondary | Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1 | Baseline up to disease progression or study treatment discontinuation (up to 38 months) | DCR was defined as the percentage of participants with observed tumor response of CR, PR or stable disease (SD) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir). The percentages of participants are rounded off to the nearest single decimal point. |
| Secondary | Duration of Response (DoR) According to RECIST Version 1.1 | From first occurrence of documented CR or PR up to disease progression or study treatment discontinuation (assessed every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 38 months) | DoR was determined for participants who had a best overall response of CR or PR. CR was defined as the disappearance of all target lesions with a reduction in target/non-target pathological lymph nodes to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DoR was defined as the time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment. |
| Secondary | Progression-Free Survival (PFS) According to RECIST Version 1.1 | Study treatment initiation up to disease progression or study treatment discontinuation (up to 38 months) | PFS was defined as the time from study treatment initiation (Cycle 1 Day 1 \[1 cycle=14 days for QW/Q2W cohorts; 1 cycle=21 days for Q3W cohorts\]) to the first occurrence of documented disease progression (based on Investigator's assessment) or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment. |
| Secondary | Overall Survival (OS) | From first dose of study treatment up to death due to any cause (up to approximately 47 months) | OS was defined as the time from the first dose of study treatment to the time of death from any cause on study. Participants who were still alive at the time of analysis were censored at the last date known alive. |
| Secondary | Percentage of Participants With Adverse Events (AEs) | Baseline up to end of the study (up to approximately 47 months) | An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Secondary | Percentage of Participants by Programmed Death-Ligand 1 (PD-L1) Status According to Immunohistochemical Methods | Baseline | |
| Secondary | Change From Baseline in Density of Cluster of Differentiation (CD) 8 Positive (CD8+) Cells According to Immunohistochemical Methods | Baseline up 2 months | |
| Secondary | Change From Baseline in Density of Cluster of Differentiation 3 Negative (CD3-) Perforin Positive Cells According to Immunohistochemical Methods | Baseline up to 2 months | |
| Secondary | Change From Baseline in Density of PD-L1 According to Immunohistochemical Methods | Baseline up to 2 months |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Baseline up to disease progression or study treatment discontinuation (up to 38 months) | Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1 | Baseline up to disease progression or study treatment discontinuation (up to 38 months) | Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) According to RECIST Version 1.1 | From first occurrence of documented CR or PR up to disease progression or study treatment discontinuation (assessed every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 38 months) | Data was not collected for this outcome measure due to premature termination of the study by the sponsor. | ||
| SECONDARY | Progression-Free Survival (PFS) According to RECIST Version 1.1 | Study treatment initiation up to disease progression or study treatment discontinuation (up to 38 months) | Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From first dose of study treatment up to death due to any cause (up to approximately 47 months) | Response evaluable population included all participants in the safety population who received at least one dose of simlukafusp alfa/atezolizumab and who had at least one baseline and one on-study tumor assessment. Due to early termination of the study, matured median for OS could not be achieved, hence as planned and pre-specified in the protocol, the data for OS was not analyzed and not reported. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) | Baseline up to end of the study (up to approximately 47 months) | Safety Population included all participants who received at least one dose of study treatment, whether prematurely withdrawn from the study or not. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants by Programmed Death-Ligand 1 (PD-L1) Status According to Immunohistochemical Methods | Baseline | Data was not collected for this outcome measure post-baseline as baseline data was not matured and sufficient to analyze PD-L1 impact. | ||
| SECONDARY | Change From Baseline in Density of Cluster of Differentiation (CD) 8 Positive (CD8+) Cells According to Immunohistochemical Methods | Baseline up 2 months | Data was not collected for this outcome measure post-baseline as baseline data was not matured and sufficient to be analyzed during analysis. | ||
| SECONDARY | Change From Baseline in Density of Cluster of Differentiation 3 Negative (CD3-) Perforin Positive Cells According to Immunohistochemical Methods | Baseline up to 2 months | Data was not collected for this outcome measure post-baseline as baseline data was not matured and sufficient to be analyzed during analysis. | ||
| SECONDARY | Change From Baseline in Density of PD-L1 According to Immunohistochemical Methods | Baseline up to 2 months | Data was not collected for this outcome measure post-baseline as baseline data was not matured and sufficient to analyze PD-L1 impact. |
Source ClinicalTrials.gov
Results by group71
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | NSCLC: Part I Cohort A (QW/Q2W) | 19.2 | 95% Confidence Interval 8.51 to 37.88 | percentage of participants | |
| Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | NSCLC: Part I Cohort B (QW/Q2W) | 6.3 | 95% Confidence Interval 1.73 to 20.15 | percentage of participants | |
| Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | 0 | 95% Confidence Interval 0.00 to 56.15 | percentage of participants | |
| Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | NSCLC: Part I Cohort D, Arm 2 (Q3W) | 0 | 95% Confidence Interval 0.00 to 43.45 | percentage of participants | |
| Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | NSCLC: Part I Cohort F (Q3W) | 4.8 | 95% Confidence Interval 0.85 to 22.67 | percentage of participants | |
| Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | 66.7 | 95% Confidence Interval 20.77 to 93.85 | percentage of participants | |
| Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | NSCLC: Part II Cohort E, Arm 2 (Q3W) | 50.0 | 95% Confidence Interval 9.45 to 90.55 | percentage of participants | |
| Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | SCCHN: Part III Cohort G (Q3W) | 18.2 | 95% Confidence Interval 7.31 to 38.52 | percentage of participants | |
| Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | SCCHN: Part III Cohort H (Q3W) | 3.6 | 95% Confidence Interval 0.63 to 17.71 | percentage of participants | |
| Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | ESCC: Part III Cohort I (Q3W) | 21.9 | 95% Confidence Interval 11.02 to 38.75 | percentage of participants |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NSCLC: Part I Cohort A (QW/Q2W) | 26 | |
| Overall Study | STARTED | NSCLC: Part I Cohort B (QW/Q2W) | 32 | |
| Overall Study | STARTED | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | 3 | |
| Overall Study | STARTED | NSCLC: Part I Cohort D, Arm 2 (Q3W) | 5 | |
| Overall Study | STARTED | NSCLC: Part I Cohort D, Arm 3 (Q3W) | 2 | |
| Overall Study | STARTED | NSCLC: Part I Cohort F (Q3W) | 22 | |
| Overall Study | STARTED | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | 3 | |
| Overall Study | STARTED | NSCLC: Part II Cohort E, Arm 2 (Q3W) | 2 | |
| Overall Study | STARTED | SCCHN: Part III Cohort G (Q3W) | 23 | |
| Overall Study | STARTED | SCCHN: Part III Cohort H (Q3W) | 30 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events4,620
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | NSCLC: Part I Cohort A (QW/Q2W) | 3 | 26 | 3 |
| other | ANAEMIA | Blood and lymphatic system disorders | NSCLC: Part I Cohort B (QW/Q2W) | 11 | 32 | 18 |
| other | ANAEMIA | Blood and lymphatic system disorders | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | NSCLC: Part I Cohort D, Arm 2 (Q3W) | 1 | 5 | 3 |
| other | ANAEMIA | Blood and lymphatic system disorders | NSCLC: Part I Cohort D, Arm 3 (Q3W) | 0 | 2 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | NSCLC: Part I Cohort F (Q3W) | 5 | 22 | 7 |
| other | ANAEMIA | Blood and lymphatic system disorders | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | 0 | 3 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | NSCLC: Part II Cohort E, Arm 2 (Q3W) | 0 | 2 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | SCCHN: Part III Cohort G (Q3W) | 15 | 23 | 29 |
| other | ANAEMIA | Blood and lymphatic system disorders | SCCHN: Part III Cohort H (Q3W) | 9 | 30 | 13 |
1 to 10 of 4,620Source ClinicalTrials.gov
See all 4,620 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NSCLC: Part I Cohort A (QW/Q2W) | 12 | 26 |
| Total, all-cause mortality | NSCLC: Part I Cohort B (QW/Q2W) | 21 | 32 |
| Total, all-cause mortality | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | 3 | 3 |
| Total, all-cause mortality | NSCLC: Part I Cohort D, Arm 2 (Q3W) | 5 | 5 |
| Total, all-cause mortality | NSCLC: Part I Cohort D, Arm 3 (Q3W) | 1 | 2 |
| Total, all-cause mortality | NSCLC: Part I Cohort F (Q3W) | 12 | 22 |
| Total, all-cause mortality | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | 1 | 3 |
| Total, all-cause mortality | NSCLC: Part II Cohort E, Arm 2 (Q3W) | 1 | 2 |
| Total, all-cause mortality | SCCHN: Part III Cohort G (Q3W) | 14 | 23 |
| Total, all-cause mortality | SCCHN: Part III Cohort H (Q3W) | 20 | 30 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03386721
GET https://conductscience.org/api/trials/v1/NCT03386721/results?page=2