Trial · NCT03498521
A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site
NCT03498521, Phase 2, Completed, Hoffmann-La Roche; results first posted 2024-06-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site. Trials, record NCT03498521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03498521
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site
- NCT number
- NCT03498521
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 529 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Cancer of Unknown Primary Site
- Interventions
Alectinib, Vismodegib, Ipatasertib, Olaparib, Erlotinib, Bevacizumab, Vemurafenib, Cobimetinib, Trastuzumab Subcutaneous (SC), Pertuzumab, Atezolizumab, Carboplatin, Paclitaxel, Cisplatin, Gemcitabine, Entrectinib, Ivosidenib, Pemigatinib
- First posted
- 2018-04-13
- Last updated
- 2025-11-19
- Other registries' IDs
- eudract:2017-003040-20
- Results first posted
- 2024-06-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | From randomization to the first occurrence of disease progression or death from any cause, until 330 PFS events were observed (approx. 4.3 years for MGT Cat 1 and 3.4 years for Chemotherapy Cat 1). | This efficacy objective was to evaluate the efficacy of MGT vs platinum chemotherapy in term of PFS in participants with CUP whose best response to 3 cycles of platinum induction chemotherapy was assessed CR, PR, or SD. |
| Secondary | Overall Survival (OS) | From randomization to death from any cause (approx. 4 years) | |
| Secondary | Objective Response Rate (ORR) | Two consecutive occurrences of complete or partial response >/=4 weeks apart (up to approximately 4 months) | |
| Secondary | Duration of Response (DOR) | From the first documentation of a complete response (CR) or partial response (PR) to disease progression or death from any cause, whichever occurs first (up to approximately 4 years) | |
| Secondary | Disease Control Rate (DCR) | From randomization to death from any cause, through the end of study (approximately 4 years) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | From randomization to the first occurrence of disease progression or death from any cause, until 330 PFS events were observed (approx. 4.3 years for MGT Cat 1 and 3.4 years for Chemotherapy Cat 1). | The intent-to-treat (ITT) population included all Category 1 randomized participants, whether or not the assigned study treatment was received. Endpoints for Category 2 were exploratory and were not included in this analysis. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization to death from any cause (approx. 4 years) | The ITT population included all Category 1 randomized participants, whether or not the assigned study treatment was received. Endpoints for Category 2 were exploratory and were not included in this analysis. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Two consecutive occurrences of complete or partial response >/=4 weeks apart (up to approximately 4 months) | The ITT population included all Cat. 1 randomized participants, whether or not the assigned study treatment was received. Cat. 2 endpoints were exploratory and not analyzed.~NA: Participants had no lesions to report at baseline NE: Post-baseline assessments reported not evaluable for any reason or if SD assessment was within 6 weeks of baseline Missing: No post-baseline assessments available | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From the first documentation of a complete response (CR) or partial response (PR) to disease progression or death from any cause, whichever occurs first (up to approximately 4 years) | Months | MEDIAN | |
| SECONDARY | Disease Control Rate (DCR) | From randomization to death from any cause, through the end of study (approximately 4 years) | Percentage of responders | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Molecularly-Guided Therapy (MGT) Category 1 | 6.14 | 95% Confidence Interval 4.70 to 6.47 | Months | |
| Progression Free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Chemotherapy Category 1 | 4.40 | 95% Confidence Interval 4.17 to 6.37 | Months | |
| Overall Survival (OS) | Molecularly-Guided Therapy MGT) Category 1 | 15.18 | 95% Confidence Interval 13.90 to 18.43 | Months | |
| Overall Survival (OS) | Chemotherapy Category 1 | 12.78 | 95% Confidence Interval 9.86 to 15.38 | Months | |
| Objective Response Rate (ORR) | Molecularly-Guided Therapy MGT) Category 1 | Complete response (CR) | 4.9 | 95% Confidence Interval 2.83 to 7.85 | Percentage of participants |
| Objective Response Rate (ORR) | Chemotherapy Category 1 | Complete response (CR) | 3.6 | 95% Confidence Interval 1.00 to 9.05 | Percentage of participants |
| Objective Response Rate (ORR) | Molecularly-Guided Therapy MGT) Category 1 | Partial response (PR) | 12.9 | 95% Confidence Interval 9.45 to 17.01 | Percentage of participants |
| Objective Response Rate (ORR) | Chemotherapy Category 1 | Partial response (PR) | 4.5 | 95% Confidence Interval 1.49 to 10.29 | Percentage of participants |
| Objective Response Rate (ORR) | Molecularly-Guided Therapy MGT) Category 1 | Stable disease (SD) | 44.5 | 95% Confidence Interval 39.00 to 50.06 | Percentage of participants |
| Objective Response Rate (ORR) | Chemotherapy Category 1 | Stable disease (SD) | 49.1 | 95% Confidence Interval 39.43 to 58.80 | Percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Molecularly-Guided Therapy (MGT) Category 1 | 326 | |
| Overall Study | STARTED | Chemotherapy Category 1 | 110 | |
| Overall Study | STARTED | Category 2 | 93 | |
| Overall Study | COMPLETED | Molecularly-Guided Therapy (MGT) Category 1 | 0 | |
| Overall Study | COMPLETED | Chemotherapy Category 1 | 0 | |
| Overall Study | COMPLETED | Category 2 | 0 | |
| Overall Study | NOT COMPLETED | Molecularly-Guided Therapy (MGT) Category 1 | 326 | |
| Overall Study | NOT COMPLETED | Chemotherapy Category 1 | 110 | |
| Overall Study | NOT COMPLETED | Category 2 | 93 |
Source ClinicalTrials.gov
Adverse events609
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 | Molecularly-Guided Therapy (MGT) Category 1 | 111 | 312 | 180 |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy Category 1 | 30 | 102 | 37 |
| other | Anaemia | Blood and lymphatic system disorders | Category 2 | 37 | 93 | 55 |
| other | Leukopenia | Blood and lymphatic system disorders | Molecularly-Guided Therapy (MGT) Category 1 | 16 | 312 | 26 |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy Category 1 | 9 | 102 | 15 |
| other | Leukopenia | Blood and lymphatic system disorders | Category 2 | 5 | 93 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Molecularly-Guided Therapy (MGT) Category 1 | 62 | 312 | 100 |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy Category 1 | 24 | 102 | 41 |
| other | Neutropenia | Blood and lymphatic system disorders | Category 2 | 11 | 93 | 13 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Molecularly-Guided Therapy (MGT) Category 1 | 49 | 312 | 80 |
1 to 10 of 609Source ClinicalTrials.gov
See all 609 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Molecularly-Guided Therapy (MGT) Category 1 | 227 | 326 |
| Total, all-cause mortality | Chemotherapy Category 1 | 79 | 110 |
| Total, all-cause mortality | Category 2 | 84 | 93 |
| Total, other adverse events | Molecularly-Guided Therapy (MGT) Category 1 | 279 | 312 |
| Total, other adverse events | Chemotherapy Category 1 | 81 | 102 |
| Total, other adverse events | Category 2 | 73 | 93 |
| Total, serious adverse events | Molecularly-Guided Therapy (MGT) Category 1 | 119 | 312 |
| Total, serious adverse events | Chemotherapy Category 1 | 15 | 102 |
| Total, serious adverse events | Category 2 | 39 | 93 |
Source ClinicalTrials.gov
Papers2
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/NCT03498521
GET https://conductscience.org/api/trials/v1/NCT03498521/results?page=2