Trial · NCT02404441
Phase I/II Study of PDR001 in Patients With Advanced Malignancies
NCT02404441, Phase 1, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-09-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase I/II Study of PDR001 in Patients With Advanced Malignancies. Trials, record NCT02404441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02404441
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I/II Study of PDR001 in Patients With Advanced Malignancies
- NCT number
- NCT02404441
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 319 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Melanoma, Non-small Sell Lung Cancer (NSCLC), Triple Negative Breast Cancer, Anaplastic Thyroid Cancer, Other Solid Tumors
- Interventions
- PDR001
- First posted
- 2015-03-31
- Last updated
- 2022-08-03
- Other registries' IDs
- eudract:2014-003929-17
- Results first posted
- 2021-09-29
- Limitations and caveats
- Although the study had 2 'arms', the phase I part of the study had 5 dosing cohorts and the phase ll part had 5 treatment groups for a total of 10 reporting groups.
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase l: The Exposure (AUC(0-336h)) After First Dose of Treatment at Cycle 3 (Each Cycle = 28 Days) | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (cycle 3) | Estimated the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) for PDR001. AUC0-336h is the AUC from time zero to 336 hour post dose of a measurable concentration sampling time. |
| Primary | Phase l: Incidence of Dose Limiting Toxicities (DLTs) | 8 months | DLT is defined as an adverse event (AE) or abnormal laboratory value of common terminology criteria for adverse events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first cycle of treatment with PDR001 during the dose escalation part of the study for which relationship to study treatment cannot be ruled out, with some exceptions. |
| Primary | Phase ll: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | 61 months | ORR is the percentage of participants with a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 CR = at least 2 determinations of CR at least 4 weeks apart before progression where confirmation required or 1 determination of CR prior to progression where confirmation not required. PR = at least 2 determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or 1 determination of PR prior to progression where confirmation not required. RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment. |
| Secondary | Phase I: Serum Pharmacokinetic (PK) Parameter AUCs (AUC0-336h (Cycle 1 Only), AUCinf, AUClast AUCtau) | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (cycle 1 & 3) | AUC0-336h is the AUC from time zero to 336 hour post dose of a measurable concentration sampling time. AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1). AUCinf: The AUC from time zero to infinity (mass x time x volume-1). AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1). |
| Secondary | Phase I: Serum Pharmacokinetic (PK) Parameter Cmax | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (Cycle 1 & 3) | The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1) |
| Secondary | Phase I: Serum Pharmacokinetic (PK) Parameter Tmax | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (cycle 1 & 3) | The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time) |
| Secondary | Phase ll: Serum Pharmacokinetic (PK) Parameter AUCs (AUC336h, AUCinf, AUClast, AUCtau) | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (cycle 1 & 3) | AUC0-336h is the AUC from time zero to 336 hour post dose of a measurable concentration sampling time. AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1). AUCinf: The AUC from time zero to infinity (mass x time x volume-1). AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1). |
| Secondary | Phase ll: Serum Pharmacokinetic (PK) Parameter Cmax | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (Cycle 1 & 3) | The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1) |
| Secondary | Phase ll: Serum Pharmacokinetic (PK) Parameter Tmax | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (Cycle 1 & 3) | The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time) |
| Secondary | Phase I: Presence and/or Concentration of Anti-PDR001 | 42 months | Assessed PDR001 anti-drug anti-body (ADA) incidence in Phase I patients - the emergence of anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of PDR001. Each cycle = 28 days; End of treatment was expected to be on average 1 year after the start of study treatment. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase l: The Exposure (AUC(0-336h)) After First Dose of Treatment at Cycle 3 (Each Cycle = 28 Days) | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (cycle 3) | Pharmacokinetic analysis set (PAS): The PAS consisted of all subjects who had at least one blood sample providing evaluable PK data. | day*ug/mL | GEOMETRIC_MEAN |
| PRIMARY | Phase l: Incidence of Dose Limiting Toxicities (DLTs) | 8 months | Safety Set: The Safety Set included all subjects from the FAS who received at least one dose of spartalizumab and had at least one valid post-baseline safety assessment. | Participants | NUMBER |
| PRIMARY | Phase ll: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | 61 months | Full Analysis Set (FAS): The FAS included all subjects who received at least one dose of spartalizumab. Subjects were analyzed according to the planned treatment (dose level and regimen). | Percentage of participants | NUMBER |
| SECONDARY | Phase I: Serum Pharmacokinetic (PK) Parameter AUCs (AUC0-336h (Cycle 1 Only), AUCinf, AUClast AUCtau) | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (cycle 1 & 3) | Pharmacokinetic analysis set (PAS): The PAS consisted of all subjects who had at least one blood sample providing evaluable PK data. | day*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase I: Serum Pharmacokinetic (PK) Parameter Cmax | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (Cycle 1 & 3) | Pharmacokinetic analysis set (PAS): The PAS consisted of all subjects who had at least one blood sample providing evaluable PK data. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase I: Serum Pharmacokinetic (PK) Parameter Tmax | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (cycle 1 & 3) | Pharmacokinetic analysis set (PAS): The PAS consisted of all subjects who had at least one blood sample providing evaluable PK data. | hour | MEDIAN |
| SECONDARY | Phase ll: Serum Pharmacokinetic (PK) Parameter AUCs (AUC336h, AUCinf, AUClast, AUCtau) | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (cycle 1 & 3) | Pharmacokinetic analysis set (PAS): The PAS consisted of all subjects who had at least one blood sample providing evaluable PK data. | day*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase ll: Serum Pharmacokinetic (PK) Parameter Cmax | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (Cycle 1 & 3) | Pharmacokinetic analysis set (PAS): The PAS consisted of all subjects who had at least one blood sample providing evaluable PK data. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Phase ll: Serum Pharmacokinetic (PK) Parameter Tmax | Predose, 1hour (h), 24h, 48h, 72h, 168h, 240h, 336h post dose (Cycle 1 & 3) | Pharmacokinetic analysis set (PAS): The PAS consisted of all subjects who had at least one blood sample providing evaluable PK data. | hour | MEDIAN |
| SECONDARY | Phase I: Presence and/or Concentration of Anti-PDR001 | 42 months | Immunogenicity incidence Set: The Immunogenicity incidence set includes all subjects in FAS with a determinant baseline immunoglobulin (IG) sample and at least one determinant post-baseline IG sample.~Treatment-induced ADA-positive was performed on ADA-positive patients only. Treatment-boosted ADA-positive was performed on ADA-positive patients only. | Participants | NUMBER |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group313
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase l: The Exposure (AUC(0-336h)) After First Dose of Treatment at Cycle 3 (Each Cycle = 28 Days) | 1mg/kg q2w | 270 | Geometric Coefficient of Variation 52.5 | day*ug/mL | |
| Phase l: The Exposure (AUC(0-336h)) After First Dose of Treatment at Cycle 3 (Each Cycle = 28 Days) | 3mg/kg q2w | 1150 | Geometric Coefficient of Variation 51.1 | day*ug/mL | |
| Phase l: The Exposure (AUC(0-336h)) After First Dose of Treatment at Cycle 3 (Each Cycle = 28 Days) | 10mg/kg q2w | 3110 | Geometric Coefficient of Variation 33.1 | day*ug/mL | |
| Phase l: The Exposure (AUC(0-336h)) After First Dose of Treatment at Cycle 3 (Each Cycle = 28 Days) | 3mg/kg q4w | 575 | Geometric Coefficient of Variation 21.8 | day*ug/mL | |
| Phase l: The Exposure (AUC(0-336h)) After First Dose of Treatment at Cycle 3 (Each Cycle = 28 Days) | 5mg/kg q4w | 1490 | Geometric Coefficient of Variation 34.2 | day*ug/mL | |
| Phase l: Incidence of Dose Limiting Toxicities (DLTs) | 1mg/kg q2w | 0 | Participants | ||
| Phase l: Incidence of Dose Limiting Toxicities (DLTs) | 3mg/kg q2w | 0 | Participants | ||
| Phase l: Incidence of Dose Limiting Toxicities (DLTs) | 10mg/kg q2w | 0 | Participants | ||
| Phase l: Incidence of Dose Limiting Toxicities (DLTs) | 3mg/kg q4w | 0 | Participants | ||
| Phase l: Incidence of Dose Limiting Toxicities (DLTs) | 5mg/kg q4w | 0 | Participants |
1 to 10 of 313Source ClinicalTrials.gov
See all 313 results by groupParticipant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 Part | STARTED | 1mg/kg q2w | 16 | |
| Phase 1 Part | STARTED | 3mg/kg q2w | 15 | |
| Phase 1 Part | STARTED | 10mg/kg q2w | 11 | |
| Phase 1 Part | STARTED | 3mg/kg q4w | 6 | |
| Phase 1 Part | STARTED | 5mg/kg q4w | 10 | |
| Phase 1 Part | STARTED | NSCLC 400mg/q4w | 0 | |
| Phase 1 Part | STARTED | Melanoma 400mg/q4w | 0 | |
| Phase 1 Part | STARTED | TNBC 400mg/q4w | 0 | |
| Phase 1 Part | STARTED | NSCLC 300mg/q3w | 0 | |
| Phase 1 Part | STARTED | ATC 400 mg/q4w | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events4,648
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 | 1mg/kg q2w | 5 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | 3mg/kg q2w | 7 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | 10mg/kg q2w | 2 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | All Phase I q2w | 14 | 42 | |
| other | Anaemia | Blood and lymphatic system disorders | 3mg/kg q4w | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | 5mg/kg q4w | 3 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | All Phase I q4w | 4 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | All Phase I Patients | 18 | 58 | |
| other | Anaemia | Blood and lymphatic system disorders | NSCLC 400mg/q4w | 16 | 59 | |
| other | Anaemia | Blood and lymphatic system disorders | Melanoma 400mg/q4w | 13 | 61 |
1 to 10 of 4,648Source ClinicalTrials.gov
See all 4,648 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1mg/kg q2w | 2 | 16 |
| Total, all-cause mortality | 3mg/kg q2w | 2 | 15 |
| Total, all-cause mortality | 10mg/kg q2w | 1 | 11 |
| Total, all-cause mortality | All Phase I q2w | 5 | 42 |
| Total, all-cause mortality | 3mg/kg q4w | 1 | 6 |
| Total, all-cause mortality | 5mg/kg q4w | 2 | 10 |
| Total, all-cause mortality | All Phase I q4w | 3 | 16 |
| Total, all-cause mortality | All Phase I Patients | 8 | 58 |
| Total, all-cause mortality | NSCLC 400mg/q4w | 4 | 59 |
| Total, all-cause mortality | Melanoma 400mg/q4w | 4 | 61 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 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/NCT02404441
GET https://conductscience.org/api/trials/v1/NCT02404441/registered?page=2