Trial · NCT03365791
PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies
NCT03365791, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-04-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies. Trials, record NCT03365791. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03365791
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies
- NCT number
- NCT03365791
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
Small Cell Lung Cancer, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Castration Resistant Prostate Adenocarcinoma, Soft Tissue Sarcoma, Ovarian Adenocarcinoma, Advanced Well-differentiated Neuroendocrine Tumors, Diffuse Large B Cell Lymphoma
- Interventions
- PDR001, LAG525
- First posted
- 2017-12-07
- Last updated
- 2022-05-27
- Results first posted
- 2021-04-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma | 24 weeks | CBR is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) and Stable Disease (SD). Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. CBR (CR+PR+SD) is reported overall and by tumor type. |
| Secondary | Overall Response Rate (ORR) | From start of treatment until end of treatment, assessed up to 113 weeks | ORR is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. ORR (CR+PR) is reported overall (including all tumor types). |
| Secondary | Time to Response (TTR) | From start of treatment to the first documented response of either complete response or partial response, assessed up to 113 weeks | TTR is defined as the time from the date of first dose to the date of first documented response of Complete Response (CR) or Partial Response (PR). In case of solid tumor if a patient did not achieve a confirmed response they were censored at maximum follow-up for patients who had a PFS event (progressed or died due to any cause), or at last adequate tumor assessment date otherwise. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). |
| Secondary | Duration of Response (DOR) | From first documented response (CR or PR) to first documented progression or death, assessed up to 113 weeks | DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time between the date of first documented response (CR or PR) and the date of first documented progression/relapse or death due to any cause within 150 days of the last study drug dose date. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). |
| Secondary | Time to Progression (TTP) | From start of treatment to first documented progression or death due to underlying cancer, assessed up to 113 weeks | TTP is the time from start of treatment to the date of event defined as the first documented progression or death due to underlying cancer. If a patient not had an event, time to progression was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). |
| Secondary | Progression-Free Survival (PFS) | From start of treatment to first documented progression or death, assessed up to 113 weeks | PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 150 days of the last dose. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment until last dose of study treatment plus 150 days post treatment, assessed up to 135 weeks. | Number of participants with AEs and SAEs including changes in laboratory parameters, vital signs and ECGs qualifying and reported as AEs. |
| Secondary | Number of Participants With Dose Interruptions and Permanent Discontinuation of Study Drug | From first dose of study treatment until last dose of study treatment, assessed up to 113 weeks. | Number of participants with at least one dose interruption of PDR001 and LAG525 and number of participants with permanent dose discontinuation of PDR001 and LAG525. |
| Secondary | Dose Intensity | From first dose of study treatment until last dose of study treatment, assessed up to 113 weeks. | Dose intensity (mg/day) of PDR001 and LAG525 is calculated as cumulative dose in milligrams divided by duration of exposure in days. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma | 24 weeks | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) | From start of treatment until end of treatment, assessed up to 113 weeks | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Response (TTR) | From start of treatment to the first documented response of either complete response or partial response, assessed up to 113 weeks | Full Analysis Set (FAS) | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From first documented response (CR or PR) to first documented progression or death, assessed up to 113 weeks | Participants in the Full Analysis Set (FAS) for whom best overall response is complete response (CR) or partial response (PR) | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) | From start of treatment to first documented progression or death due to underlying cancer, assessed up to 113 weeks | Full Analysis Set (FAS) | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | From start of treatment to first documented progression or death, assessed up to 113 weeks | Full Analysis Set (FAS) | months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study treatment until last dose of study treatment plus 150 days post treatment, assessed up to 135 weeks. | All participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Dose Interruptions and Permanent Discontinuation of Study Drug | From first dose of study treatment until last dose of study treatment, assessed up to 113 weeks. | All participants who received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Intensity | From first dose of study treatment until last dose of study treatment, assessed up to 113 weeks. | All participants who received at least one dose of study treatment | mg/day | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma | PDR001+LAG525 | Overall | 25 | Participants | |
| Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma | PDR001+LAG525 | Small cell lung cancer | 3 | Participants | |
| Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma | PDR001+LAG525 | Gastric/esophageal adenocarcinoma | 2 | Participants | |
| Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma | PDR001+LAG525 | Castration resistant prostate adenocarcinoma (CRPC) | 5 | Participants | |
| Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma | PDR001+LAG525 | Soft tissue sarcoma | 4 | Participants | |
| Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma | PDR001+LAG525 | Ovarian adenocarcinoma | 2 | Participants | |
| Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma | PDR001+LAG525 | Advanced well-differentiated neuroendocrine tumors | 6 | Participants | |
| Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma | PDR001+LAG525 | Diffuse large B cell lymphoma (DLBCL) | 3 | Participants | |
| Overall Response Rate (ORR) | PDR001+LAG525 | 7 | Participants | ||
| Time to Response (TTR) | PDR001+LAG525 | NA | 95% Confidence Interval NA to NA | months |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PDR001+LAG525 | 76 | |
| Overall Study | Full Analysis Set (FAS) | PDR001+LAG525 | 75 | |
| Overall Study | COMPLETED | PDR001+LAG525 | 4 | |
| Overall Study | NOT COMPLETED | PDR001+LAG525 | 72 |
Source ClinicalTrials.gov
Adverse events184
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 | PDR001+LAG525 On-treatment Period | 13 | 76 | |
| other | Anaemia | Blood and lymphatic system disorders | PDR001+LAG525 Extended Safety Follow-up Period | 2 | 76 | |
| other | Dizziness | Cardiac disorders | PDR001+LAG525 On-treatment Period | 6 | 76 | |
| other | Dizziness | Cardiac disorders | PDR001+LAG525 Extended Safety Follow-up Period | 2 | 76 | |
| other | Dyspnoea | Cardiac disorders | PDR001+LAG525 On-treatment Period | 18 | 76 | |
| other | Dyspnoea | Cardiac disorders | PDR001+LAG525 Extended Safety Follow-up Period | 1 | 76 | |
| other | Oedema peripheral | Cardiac disorders | PDR001+LAG525 On-treatment Period | 10 | 76 | |
| other | Oedema peripheral | Cardiac disorders | PDR001+LAG525 Extended Safety Follow-up Period | 1 | 76 | |
| other | Hypercalcaemia | Endocrine disorders | PDR001+LAG525 On-treatment Period | 5 | 76 | |
| other | Hypercalcaemia | Endocrine disorders | PDR001+LAG525 Extended Safety Follow-up Period | 0 | 76 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PDR001+LAG525 On-treatment Period | 9 | 76 |
| Total, all-cause mortality | PDR001+LAG525 Extended Safety Follow-up Period | 18 | 76 |
| Total, other adverse events | PDR001+LAG525 On-treatment Period | 74 | 76 |
| Total, other adverse events | PDR001+LAG525 Extended Safety Follow-up Period | 12 | 76 |
| Total, serious adverse events | PDR001+LAG525 On-treatment Period | 31 | 76 |
| Total, serious adverse events | PDR001+LAG525 Extended Safety Follow-up Period | 4 | 76 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PDR001+LAG525 On-treatment Period vs PDR001+LAG525 Extended Safety Follow-up Period: deaths from any cause | Trial comparisons |
| PDR001+LAG525 On-treatment Period vs PDR001+LAG525 Extended Safety Follow-up Period: serious adverse events | Trial comparisons |
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/NCT03365791
GET https://conductscience.org/api/trials/v1/NCT03365791/results?page=2