Trial · NCT02354690

Vemurafenib and TIL Therapy for Metastatic Melanoma

NCT02354690, Phase 1, Phase 2, Completed, Inge Marie Svane; results first posted 2020-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vemurafenib and TIL Therapy for Metastatic Melanoma. Trials, record NCT02354690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02354690

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vemurafenib and TIL Therapy for Metastatic Melanoma
NCT number: NCT02354690
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 13 participants, actual
Lead sponsor: Inge Marie Svane
Conditions: Metastatic Melanoma
Interventions: Vemurafenib, Lymphodepleting chemotherapy, TIL infusion, Interleukin-2
First posted: 2015-02-03
Last updated: 2020-03-23
Results first posted: 2020-02-24

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Reported Adverse Events	0-40 weeks	Determine the safety of the administration of vemurafenib in combination with TIL therapy including lymphodepleting chemotherapy and interleukin-2 treatment by collecting adverse events according to CTCAE v. 4.0. From start of treatment until 24 weeks after T cell infusion.
Secondary	Treatment Related Immune Responses	0-24 weeks	Number of patients whose infusion product contained anti-tumor reactive T cells by in vitro testing. Anti-tumor reactive T cells is defined by positive staining for two of the three markers (interferon gamma, tumor necrosis factor alpha and CD107a) in an intracellular cytokine staining using flow cytometry.
Secondary	Objective Response Rate	Up to 12 months	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Secondary	Overall Survival	Up to 40 months	Overall survival (OS), defined as the time from the start of treatment to death, will be described with the Kaplan-Meier curve.
Secondary	Progression Free Survival	Up to 40 months	Progression-free survival (PFS), defined as the time from start of treatment to disease progression, relapse or death due to any cause, whichever is earlier, will be described with the Kaplan-Meier curve. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Reported Adverse Events	0-40 weeks	Treatment related adverse events	NUMBER
SECONDARY	Treatment Related Immune Responses	0-24 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Objective Response Rate	Up to 12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	Up to 40 months	Months	MEDIAN
SECONDARY	Progression Free Survival	Up to 40 months	Months	MEDIAN

Source ClinicalTrials.gov

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Reported Adverse Events	T Cell Therapy With Vemurafenib Pretreatment	Total	124		Treatment related adverse events
Number of Reported Adverse Events	T Cell Therapy With Vemurafenib Pretreatment	Grade 1-2	89		Treatment related adverse events
Number of Reported Adverse Events	T Cell Therapy With Vemurafenib Pretreatment	Grade 3-4	35		Treatment related adverse events
Treatment Related Immune Responses	T Cell Therapy With Vemurafenib Pretreatment		10		Participants
Objective Response Rate	T Cell Therapy With Vemurafenib Pretreatment		9		Participants
Overall Survival	T Cell Therapy With Vemurafenib Pretreatment		28.8	Full Range 5.2 to 39.9	Months
Progression Free Survival	T Cell Therapy With Vemurafenib Pretreatment		4.8	Full Range 2.5 to 36.1	Months

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	T Cell Therapy With Vemurafenib Pretreatment	13
Overall Study	COMPLETED	T Cell Therapy With Vemurafenib Pretreatment	12
Overall Study	NOT COMPLETED	T Cell Therapy With Vemurafenib Pretreatment	1

Source ClinicalTrials.gov

Adverse events34

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	Febrile neutropenia	Blood and lymphatic system disorders	T Cell Therapy With Vemurafenib Pretreatment	12	12	12
other	Infection	Infections and infestations	T Cell Therapy With Vemurafenib Pretreatment	5	12	5
other	Pyrexia	General disorders	T Cell Therapy With Vemurafenib Pretreatment	1	12	1
other	Fatique	General disorders	T Cell Therapy With Vemurafenib Pretreatment	12	12	14
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	T Cell Therapy With Vemurafenib Pretreatment	10	12	10
other	Nausea	Gastrointestinal disorders	T Cell Therapy With Vemurafenib Pretreatment	9	12	9
other	Vomiting	Gastrointestinal disorders	T Cell Therapy With Vemurafenib Pretreatment	2	12	2
other	Constipation	Gastrointestinal disorders	T Cell Therapy With Vemurafenib Pretreatment	1	12	1
other	Oral mucositis	Gastrointestinal disorders	T Cell Therapy With Vemurafenib Pretreatment	5	12	5
other	Rash maculo-papular	Skin and subcutaneous tissue disorders	T Cell Therapy With Vemurafenib Pretreatment	12	12	14

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	T Cell Therapy With Vemurafenib Pretreatment	7	12
Total, other adverse events	T Cell Therapy With Vemurafenib Pretreatment	12	12
Total, serious adverse events	T Cell Therapy With Vemurafenib Pretreatment	4	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32747469	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02354690

GET https://conductscience.org/api/trials/v1/NCT02354690/events?page=2

API reference For AI assistants