Trial · NCT03435640
REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies
NCT03435640, Phase 1, Phase 2, Terminated, Nektar Therapeutics; results first posted 2023-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies. Trials, record NCT03435640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03435640
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies
- NCT number
- NCT03435640
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Nektar Therapeutics
- Conditions
- Melanoma, Merkel Cell Carcinoma, Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma, Renal Cell Carcinoma, Colorectal Cancer, Sarcoma
- Interventions
- NKTR-262, bempegaldesleukin, nivolumab
- First posted
- 2018-02-19
- Last updated
- 2023-03-08
- Other registries' IDs
- eudract:2018-004625-84
- Results first posted
- 2023-03-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) | The DLT window is 21 days following NKTR-262 single agent administration (Cycle 1) and an additional 9 days when combined with bempeg for staggered dosing administration (Cohorts 1 and 2), or 7 days for the same day administration (Cohort 3 and higher). | DLTs were assessed in Cohort 1 through Cohort 9, which had dose levels of NKTR-262 as 0.03mg, 0.06mg, 0.06mg, 0.12mg, 0.24mg, 0.48mg, 0.96mg, 1.92mg, and 3.84mg in combination with bempegaldesleukin (bempeg). There was only 1 DLT that occurred in one of the Cohort 9 patients. Therefore, the maximum tolerated dose (MTD) of NKTR 262 was not reached. |
| Primary | Objective Response Rate (ORR) Per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D) | From Cycle 1 Day 1 to 100 days after the last dose of study drug or the date for new anti-cancer therapy, whichever is earlier. | Objective Response Rate (ORR) per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by Blinded Independent Central Review (BICR). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) | The DLT window is 21 days following NKTR-262 single agent administration (Cycle 1) and an additional 9 days when combined with bempeg for staggered dosing administration (Cohorts 1 and 2), or 7 days for the same day administration (Cohort 3 and higher). | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Objective Response Rate (ORR) Per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D) | From Cycle 1 Day 1 to 100 days after the last dose of study drug or the date for new anti-cancer therapy, whichever is earlier. | safety population | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) | Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered) | 0 | Participants | ||
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) | Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered) | 0 | Participants | ||
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) | Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day) | 0 | Participants | ||
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) | Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day) | 0 | Participants | ||
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) | Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day) | 0 | Participants | ||
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) | Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day) | 0 | Participants | ||
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) | Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day) | 0 | Participants | ||
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) | Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day) | 0 | Participants | ||
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) | Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day) | 1 | Participants | ||
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTS) | Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day) | 0 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered) | 3 | |
| Overall Study | STARTED | Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered) | 3 | |
| Overall Study | STARTED | Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day) | 4 | |
| Overall Study | STARTED | Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day) | 3 | |
| Overall Study | STARTED | Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day) | 4 | |
| Overall Study | STARTED | Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day) | 4 | |
| Overall Study | STARTED | Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day) | 4 | |
| Overall Study | STARTED | Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day) | 3 | |
| Overall Study | STARTED | Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day) | 8 | |
| Overall Study | STARTED | Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day) | 14 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events3,058
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 | Fatigue | General disorders | Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered) | 2 | 3 | |
| other | Fatigue | General disorders | Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered) | 3 | 3 | |
| other | Fatigue | General disorders | Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day) | 2 | 4 | |
| other | Fatigue | General disorders | Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day) | 1 | 3 | |
| other | Fatigue | General disorders | Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day) | 3 | 4 | |
| other | Fatigue | General disorders | Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day) | 2 | 4 | |
| other | Fatigue | General disorders | Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day) | 3 | 4 | |
| other | Fatigue | General disorders | Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day) | 1 | 3 | |
| other | Fatigue | General disorders | Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day) | 4 | 8 | |
| other | Fatigue | General disorders | Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day) | 8 | 14 |
1 to 10 of 3,058Source ClinicalTrials.gov
See all 3,058 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered) | 2 | 3 |
| Total, all-cause mortality | Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered) | 2 | 3 |
| Total, all-cause mortality | Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day) | 3 | 4 |
| Total, all-cause mortality | Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day) | 1 | 3 |
| Total, all-cause mortality | Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day) | 4 | 4 |
| Total, all-cause mortality | Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day) | 4 | 4 |
| Total, all-cause mortality | Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day) | 1 | 4 |
| Total, all-cause mortality | Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day) | 2 | 3 |
| Total, all-cause mortality | Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day) | 5 | 8 |
| Total, all-cause mortality | Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day) | 9 | 14 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35444059 | 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/NCT03435640
GET https://conductscience.org/api/trials/v1/NCT03435640/flow?page=2