Trial · NCT02923531
Addition of X4P-001 to Nivolumab Treatment in Participants With Renal Cell Carcinoma
NCT02923531, Phase 1, Phase 2, Terminated, X4 Pharmaceuticals; results first posted 2022-12-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Addition of X4P-001 to Nivolumab Treatment in Participants With Renal Cell Carcinoma. Trials, record NCT02923531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02923531
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Addition of X4P-001 to Nivolumab Treatment in Participants With Renal Cell Carcinoma
- NCT number
- NCT02923531
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- X4 Pharmaceuticals
- Conditions
- Clear Cell Renal Cell Carcinoma
- Interventions
- X4P-001, Nivolumab
- First posted
- 2016-10-04
- Last updated
- 2022-12-29
- Results first posted
- 2022-12-29
- Limitations and caveats
- Due to low enrollment, the study was terminated early. Data for some pre-registered endpoints were therefore not collected or analysed and could not be reported.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From administration of first dose of study medication (Day 1) up to 30 days after last dose (up to 16 months) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Drug-related TEAEs: TEAEs with possible, probable, definite, or missing relationship to study medication (X4P-001 or Nivolumab). Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as events occurring on or after the first dose of study drug through 30 days after the last dose. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in Reported AE section. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of X4P-001 | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 | Samples were to be analyzed for X4P-001 concentration using reversed-phase high performance liquid chromatography (RP-HPLC) with tandem mass spectrometry (MS) detection. |
| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC) of X4P-001 | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 | Samples were to be analyzed for X4P-001 concentration using RP-HPLC with tandem MS detection. |
| Secondary | Minimum Plasma Concentration (Cmin) of X4P-001 | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 | Samples were to be analyzed for X4P-001 concentration using RP-HPLC with tandem MS detection. |
| Secondary | Time to Reach Cmax (Tmax) of X4P-001 | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 | Samples were to be analyzed for X4P-001 concentration using RP-HPLC with tandem MS detection. |
| Secondary | Objective Response Rate (ORR): Percentage of Participants With Objective Response, Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From administration of first dose of study medication (Day 1) until disease progression, study completion or early termination (up to 15 months) | ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to less than (\<) 10 millimeters (mm). PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Duration of Objective Response (DOR), Evaluated Using RECIST Version 1.1 | Time from first CR or PR until the time of disease progression or death due to any cause (up to 15 months) | DOR was defined as the time from first CR or PR whichever comes first until the time of disease progression by RECIST v1.1 or death due to any cause. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of 1 or more new lesions was also considered progression. |
| Secondary | Time to Objective Response, Evaluated Using RECIST Version 1.1 | From administration of first dose of study medication (Day 1) until first appearance of CR or PR (up to 15 months) | Time to objective response was defined as time from first administration of combination regimen to first CR or PR whichever comes first. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Disease Control Rate: Percentage of Participants With CR or PR or Stable Disease (SD), Evaluated Using RECIST Version 1.1 | From administration of first dose of study medication (Day 1) until disease progression, study completion or early termination (up to 15 months) | Disease control rate was defined as percentage of participants with best overall response of CR or PR or SD. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) with a reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of 1 or more new lesions was also considered progression. |
| Secondary | Progression Free Survival (PFS), Evaluated Using RECIST Version 1.1 | From administration of first dose of study medication (Day 1) until disease progression or death from any cause (up to 15 months) | PFS was defined as the time from first administration of study medication until objective tumor progression or death from any cause. Tumor progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. An unequivocal progression of existing non-target lesions or the appearance of 1 or more new lesions was also considered progression. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From administration of first dose of study medication (Day 1) up to 30 days after last dose (up to 16 months) | Safety population included all participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of X4P-001 | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 | The study was terminated and the pharmacokinetic (PK) samples collected could not be analyzed due to insufficient data available to assess the outcome measure as per the prespecified method of analysis. | ||
| SECONDARY | Area Under the Plasma Concentration Versus Time Curve (AUC) of X4P-001 | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 | The study was terminated and the PK samples collected could not be analyzed due to insufficient data available to assess the outcome measure as per the prespecified method of analysis. | ||
| SECONDARY | Minimum Plasma Concentration (Cmin) of X4P-001 | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 | The study was terminated and the PK samples collected could not be analyzed due to insufficient data available to assess the outcome measure as per the prespecified method of analysis. | ||
| SECONDARY | Time to Reach Cmax (Tmax) of X4P-001 | Predose (-30 minutes) on Day 1 of Cycle 1; predose (-10 minutes) on Days 8, 15, and 22 of Cycle 1, and Day 1 of Cycle 3; postdose at 60 and 90 minutes, and 2, 3 4, and 8 hours on Day 22 of Cycle 1 | The study was terminated and the PK samples collected could not be analyzed due to insufficient data available to as per the prespecified method of analysis. | ||
| SECONDARY | Objective Response Rate (ORR): Percentage of Participants With Objective Response, Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From administration of first dose of study medication (Day 1) until disease progression, study completion or early termination (up to 15 months) | Intent-to-treat (ITT) population included all participants who received at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Response (DOR), Evaluated Using RECIST Version 1.1 | Time from first CR or PR until the time of disease progression or death due to any cause (up to 15 months) | ITT population included all participants who received at least 1 dose of study medication. | months | MEDIAN |
| SECONDARY | Time to Objective Response, Evaluated Using RECIST Version 1.1 | From administration of first dose of study medication (Day 1) until first appearance of CR or PR (up to 15 months) | ITT population included all participants who received at least 1 dose of study medication. | months | MEDIAN |
| SECONDARY | Disease Control Rate: Percentage of Participants With CR or PR or Stable Disease (SD), Evaluated Using RECIST Version 1.1 | From administration of first dose of study medication (Day 1) until disease progression, study completion or early termination (up to 15 months) | ITT population included all participants who received at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS), Evaluated Using RECIST Version 1.1 | From administration of first dose of study medication (Day 1) until disease progression or death from any cause (up to 15 months) | ITT population included all participants who received at least 1 dose of study medication. | months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | X4P-001 Plus Nivolumab | Any TEAEs | 9 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | X4P-001 Plus Nivolumab | Serious TEAEs | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | X4P-001 Plus Nivolumab | X4P-001-Related TEAEs | 9 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | X4P-001 Plus Nivolumab | Nivolumab-Related TEAEs | 9 | Participants | |
| Objective Response Rate (ORR): Percentage of Participants With Objective Response, Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | X4P-001 Plus Nivolumab | 11.1 | 95% Confidence Interval 0.3 to 48.2 | percentage of participants | |
| Duration of Objective Response (DOR), Evaluated Using RECIST Version 1.1 | X4P-001 Plus Nivolumab | NA | 95% Confidence Interval NA to NA | months | |
| Time to Objective Response, Evaluated Using RECIST Version 1.1 | X4P-001 Plus Nivolumab | NA | 95% Confidence Interval NA to NA | months | |
| Disease Control Rate: Percentage of Participants With CR or PR or Stable Disease (SD), Evaluated Using RECIST Version 1.1 | X4P-001 Plus Nivolumab | 88.9 | 95% Confidence Interval 51.8 to 99.7 | percentage of participants | |
| Progression Free Survival (PFS), Evaluated Using RECIST Version 1.1 | X4P-001 Plus Nivolumab | NA | 95% Confidence Interval NA to NA | months | |
| Time to Progression (TTP), Evaluated Using RECIST Version 1.1 | X4P-001 Plus Nivolumab | NA | 95% Confidence Interval NA to NA | months |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | X4P-001 Plus Nivolumab | 9 | |
| Overall Study | Received at Least 1 Dose of Study Medication | X4P-001 Plus Nivolumab | 9 | |
| Overall Study | COMPLETED | X4P-001 Plus Nivolumab | 0 | |
| Overall Study | NOT COMPLETED | X4P-001 Plus Nivolumab | 9 |
Source ClinicalTrials.gov
Adverse events75
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 | Diarrhoea | Gastrointestinal disorders | X4P-001 Plus Nivolumab | 6 | 9 | |
| other | Nausea | Gastrointestinal disorders | X4P-001 Plus Nivolumab | 3 | 9 | |
| other | Dyspepsia | Gastrointestinal disorders | X4P-001 Plus Nivolumab | 2 | 9 | |
| other | Abdominal pain | Gastrointestinal disorders | X4P-001 Plus Nivolumab | 1 | 9 | |
| other | Anal incontinence | Gastrointestinal disorders | X4P-001 Plus Nivolumab | 1 | 9 | |
| other | Dry mouth | Gastrointestinal disorders | X4P-001 Plus Nivolumab | 1 | 9 | |
| other | Eructation | Gastrointestinal disorders | X4P-001 Plus Nivolumab | 1 | 9 | |
| other | Vomiting | Gastrointestinal disorders | X4P-001 Plus Nivolumab | 1 | 9 | |
| other | Dry eye | Eye disorders | X4P-001 Plus Nivolumab | 4 | 9 | |
| other | Conjunctival hyperaemia | Eye disorders | X4P-001 Plus Nivolumab | 2 | 9 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | X4P-001 Plus Nivolumab | 0 | 9 |
| Total, other adverse events | X4P-001 Plus Nivolumab | 9 | 9 |
| Total, serious adverse events | X4P-001 Plus Nivolumab | 2 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33507454 | DERIVED |
Source PubMed
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/NCT02923531
GET https://conductscience.org/api/trials/v1/NCT02923531/events?page=2