Trial · NCT01986426
LTX-315 in Patients With Transdermally Accessible Tumours as Monotherapy or Combination With Ipilimumab or Pembrolizumab
NCT01986426, Phase 1, Completed, Lytix Biopharma AS
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LTX-315 in Patients With Transdermally Accessible Tumours as Monotherapy or Combination With Ipilimumab or Pembrolizumab. Trials, record NCT01986426. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01986426
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LTX-315 in Patients With Transdermally Accessible Tumours as Monotherapy or Combination With Ipilimumab or Pembrolizumab
- NCT number
- NCT01986426
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Lytix Biopharma AS
- Conditions
- Cancer, Melanoma, Breast Cancer, Head and Neck Cancer, Lymphoma, Triple-Negative Breast Cancer
- Interventions
- LTX-315 consecutive lesions, LTX-315, LTX-315 + ipilimumab, LTX-315 + pembrolizumab
- First posted
- 2013-11-18
- Last updated
- 2018-10-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicity | 21 days | Dose limiting toxicities (DLT) and the overall safety profile (adverse events (AE), laboratory assessments, physical findings and symptomatic assessment) of LTX-315 as monotherapy and in combination with ipilimumab or pembrolizumab. |
| Secondary | Anti tumour activity in injected tumour | Every 8 weeks from treatment start up to 24 months or first documented progression documented assessed | Number of patients with regression of injected tumour assessed by ultrasound and/or CT/MRI. |
| Secondary | Complete response (irCR) and partial response (irPR) | Every 8 weeks from treatment start up to 24 months or first documented progression documented assessed | Number of patients by irRC |
| Secondary | Overall response rate (OR) | Every 8 weeks from treatment start up to 24 months or first documented progression documented assessed | (irRC criteria) |
| Secondary | Disease control rate (CR + PR + SD) | Every 8 weeks from treatment start up to 24 months or first documented progression documented assessed | irRC criteria |
| Secondary | Progression free survival (PFS) | Every 8 weeks from treatment start up to 24 months or first documented progression documented assessed | irRC criteria |
| Other | Pharmacokinetic (PK) profile of LTX-315 | Pre and 1 hour post dosing Day 2 Week 1 | Measurement of plasma concentrations of LTX-315 pre- and 1 hour post-dosing day 2 in week 1. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT01986426
GET https://conductscience.org/api/trials/v1/NCT01986426/registered