MelanomaPhase 1/2NCT02452424

A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors

A Phase 1/2 study testing PLX3397 and Pembrolizumab in people with Melanoma and Non-small Cell Lung Cancer, run by Daiichi Sankyo at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The goal of this clinical research study is to learn how PLX3397 and pembrolizumab work together to affect cancer cells. PLX3397 is designed to target the receptor for CSF1 (CSF1R). Pembrolizumab is designed to block the interaction between the receptor PD-1 and molecules that bind PD-1. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck
What is being tested?: PLX3397 and Pembrolizumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 12 sitesUnited States
Study dates: 2 Jul 2015to 12 Oct 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A subject must satisfy all of the following criteria to be considered for inclusion in the study:
Subjects with histologically or cytologically-confirmed diagnosis of cancer that is recurrent, metastatic, or persistent, who have relapsed from or are refractory to treatment and who also meet the following corresponding requirements for the cohort or phase of the study into which they will enroll:
Dose-escalation Phase: Subjects with advanced solid tumors (any tumor type) considered to have no standard-of care treatment for their malignancy with a curative intent, either as initial therapy or after progressing to prior therapies; subjects who have been treated previously with a CSF1R inhibitor or an anti PD1/PDL1 inhibitor may enroll.
Expansion Phase: Subjects with 1 of the tumor types who have relapsed from or are refractory to standard treatment. Subjects with non-small-cell lung cancer (non-squamous; EGFR, ALK wild type), advanced melanoma, ovarian cancer, unresectable RCC with component of clear-cell histology and/or component of sarcomatoid histology, glioblastoma or gliosarcoma, gastrointestinal stromal tumor.
Subjects with melanoma must have a histologically confirmed diagnosis of stage III disease not amenable to local therapy. Melanoma subjects may have received any number of prior lines of therapy for metastatic disease and must have measurable disease per RECISTv1.1. Subjects with melanoma who have received prior treatment with a BRAF/MEK inhibitor are acceptable candidates.
Expansion cohorts: Subjects must have relapsed or been refractory to standard treatment. NSCLC, SCCHN, and Melanoma must show primary progression with antiPD1/anti-PDL1 therapy. They must have tumor accessible for sequential biopsy (core needle biopsy or excision required) and be willing to provide on study tumor tissue biopsy. Subjects for whom newly obtained samples cannot be obtained (e.g. inaccessible or patient safety concern) may submit an archived specimen onlyupon agreement from the Sponsor.

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ECOG performance status 0 or 1.
Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to initiation of dosing.
Women of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Women of non-child bearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year.
Fertile men must agree to use an effective method of birth control starting with the first dose of study treatment through 120 days after the last dose of study treatment.
Adequate organ function as demonstrated by laboratory values.

Who cannot join

A subject who meets any of the following criteria will be disqualified from entering the study:
Disease that is suitable for local therapy administered with curative intent.
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days prior to the first dose of study treatment.
Has had monoclonal antibody within 28 days of first dose of study treatment or has not recovered from AEs due to agents administered more than 28 days earlier.
Has had chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to first dose of study treatment or who has not recovered from AEs due to a previously administered agent.

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Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.
Note: If a subject received major surgery, he or she must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Has received transfusion of blood products (including platelets or red blood cells [RBC]) or administration of colony stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 28 days prior to Day 1.
Evidence of interstitial lung disease or active, noninfectious pneumonitis.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer and isolated elevation of prostate-specific antigen. Subjects with a completely treated prior malignancy with no evidence of disease for ≥ 2 years are eligible.
For Dose escalation cohort: patients with liver metastases, inclusion of patients with liver metastases in subsequent cohorts will be based upon clinical data.
For Expansion cohort subjects who have previously received an anti-PD-1, anti-PD-L1, or anti#PD-L2 agent or has previously participated in pembrolizumab clinical trials are excluded, except the following tumor types Melanoma, NSCLC and SCCHN (who must show primary progression to anti-PD1/anti-PDL1 therapy).
Radiation therapy within 14 days of first dose of study treatment.- remove since it's repetitive
Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is not considered a form of systemic treatment.
Has an active infection requiring systemic therapy.
Has known central nervous system metastases and/or carcinomatous meningitis.
o Note: Subjects with previously treated brain metastases may participate if they meet the following criteria: 1) are stable for at least 28 days prior to the first dose of study treatment and if all neurologic symptoms returned to baseline); 2) have no evidence of new or enlarging brain metastases; and 3) have not been using steroids for at least 7 days prior to first dose of study treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
Uncontrolled intercurrent illness.
Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption.
QT interval corrected using Fridericia's formula (QTc) ≥ 450 msec (males) or ≥ 470 msec (females) at Screening.
Congenital long QT syndrome or patients taking concomitant medications known to prolong the QT interval.
Major surgery within 28 days prior to first dose of study treatment.
Has received a live vaccine administered within 30 days prior to first dose of study treatment.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Active and clinically significant bacterial, fungal or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome related illness (HIV testing is not required), including subjects who have an active infection requiring systemic therapy.
Any of the following within 48 weeks (~1 year) prior to first dose of study treatment: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study treatment.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has had prior exposure to PLX3397.
Has had hypersensitivity (≥Grade 3) reaction to pembrolizumab and/or any of its excipients.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Medical University Health Hollings Cancer Center
Charleston, South Carolina, 29425
Karmanos Cancer Institute
Detroit, Michigan, 48201
Marin Cancer Care
Greenbrae, California, 94904
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37212
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Washington University St. Louis Siteman Cancer Center
St Louis, Missouri, 63130

Other trials in United States

About this study

Official title: Phase 1/2a Study of Double-Immune Suppression Blockade By Combining a CSF1R Inhibitor (PLX3397) With An Anti-PD-1 Antibody (Pembrolizumab) To Treat Advanced Melanoma And Other Solid Tumors

The goal of this clinical research study is to learn how PLX3397 and pembrolizumab work together to affect cancer cells.

PLX3397 is designed to target the receptor for CSF1 (CSF1R). Pembrolizumab is designed to block the interaction between the receptor PD-1 and molecules that bind PD-1. In this study, PLX3397 and pembrolizumab are being given together in order to study their combined effects on patients' immune responses to their tumors. Tumor-specific immune responses have been shown to kill cancer cells and/or to stop tumors from growing.

Part 1 of the study (dose-escalation phase) will establish the safest dose of PLX3397 to be given in combination with pembrolizumab. Part 2 of the study (expansion phase) will include an evaluation of efficacy of this combination in the following tumor types:

Advanced melanoma: prior anti-PD-1/PD-L1 therapy but never responded
Advanced melanoma: prior anti-PD-1/PD-L1 therapy and responded but later progressed as defined by irRECIST while on therapy
Non-small cell lung cancer
Ovarian cancer
Gastrointestinal Stromal Tumor (GIST)
Squamous cell cancer of the head and neck

Conditions: Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Gastrointestinal Stromal Tumor (GIST), Ovarian Cancer
Being tested: PLX3397, Pembrolizumab
Medical subject headings: Melanoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Gastrointestinal Stromal Tumors, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PLX3397Drug
Also called Pexidartinib
PLX3397 capsules, 200 mg
PembrolizumabBiological
Also called Keytruda, MK-3475, SCH 900475
Pembrolizumab, 200 mg, IV

Study groups in NCT02452424
Study group	Role	What they receive
PLX3397 and Pembrolizumab (Part 1)	Experimental	Open-label, sequential PLX3397 dose escalation with a fixed dose of pembrolizumab in approximately 24 patients with advanced solid tumors. (Enrollment complete- 33 enrolled) Receives: Drug: PLX3397; Biological: Pembrolizumab
PLX3397 and Pembrolizumab (Part 2)	Experimental	Extension cohort at the RP2D of PLX3397 in combination with pembrolizumab in approximately 376 patients with advanced solid tumors (Enrollment Complete- 45 enrolled) Receives: Drug: PLX3397; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment-emergent Adverse Events (TEAEs) in Participants Regardless of Causality While Taking PLX3397 in Combination With Pembrolizumab
Treatment-emergent Adverse Events (TEAEs) in participants regardless of causality while taking PLX3397 in combination with pembrolizumab are reported
Measured: 1 year (Dose Escalation); 2 years (Dose Expansion)

Secondary outcomes (1)

Summary of the Percentage of Participants With Objective Response Rate Assessed by RECIST v1.1 During Pembrolizumab and PLX3397
Objective response rate was defined as the proportion of subjects who achieved a best disease response of either Complete or Partial (CR or PR) based on the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed generally by MRI, CT, or PET-CT and are summarized as: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Participants who discontinued study therapy due to clinical progression, radiographic progression, or death without the required tumor assessments were considered to be non-responders in the Objective Response Rate (ORR) calculation. The efficacy analysis included all subjects with baseline tumor measurements who received at least 1 dose of study drug.
Measured: 1 year (Dose Escalation); 2 years (Dose Expansion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 201512 Oct 2018

First posted22 May 2015 (estimated)
Study start2 Jul 2015
Primary completion17 Aug 2018
Study completion12 Oct 2018

Why it stopped: Terminated early for insufficient evidence of clinical efficacy

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MelanomaStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02452424
Sponsor's protocol ID: PLX108-14
Other IDs: KEYNOTE-103
Status last verified: Feb 2020
First submitted: 20 May 2015
Last updated: 5 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https:// vivli.org/ourmember/daiichi-sankyo/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma

All Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1/2a Study of Double-Immune Suppression Blockade By Combining a CSF1R Inhibitor (PLX3397) With An Anti-PD-1 Antibody (Pembrolizumab) To Treat Advanced Melanoma And Other Solid Tumors
ClinicalTrials.gov ID: NCT02452424
Acronym / sponsor ID: PLX108-14
Conditions: Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Gastrointestinal Stromal Tumor (GIST), Ovarian Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated early for insufficient evidence of clinical efficacy
Enrolment: 78 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Collaborators: Plexxikon, Merck Sharp & Dohme LLC
Study start: 2 Jul 2015 (actual)
Primary completion: 17 Aug 2018 (actual)
Study completion: 12 Oct 2018 (actual)
First posted: 22 May 2015 (estimated)
Results: Posted 9 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this clinical research study is to learn how PLX3397 and pembrolizumab work together to affect cancer cells.

Advanced melanoma: prior anti-PD-1/PD-L1 therapy but never responded
Advanced melanoma: prior anti-PD-1/PD-L1 therapy and responded but later progressed as defined by irRECIST while on therapy
Non-small cell lung cancer
Ovarian cancer
Gastrointestinal Stromal Tumor (GIST)
Squamous cell cancer of the head and neck

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PLX3397 and Pembrolizumab (Part 1)	Experimental	Drug: PLX3397, Biological: PembrolizumabOpen-label, sequential PLX3397 dose escalation with a fixed dose of pembrolizumab in approximately 24 patients with advanced solid tumors. (Enrollment complete- 33 enrolled)
PLX3397 and Pembrolizumab (Part 2)	Experimental	Drug: PLX3397, Biological: PembrolizumabExtension cohort at the RP2D of PLX3397 in combination with pembrolizumab in approximately 376 patients with advanced solid tumors (Enrollment Complete- 45 enrolled)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

A subject must satisfy all of the following criteria to be considered for inclusion in the study:
Subjects with histologically or cytologically-confirmed diagnosis of cancer that is recurrent, metastatic, or persistent, who have relapsed from or are refractory to treatment and who also meet the following corresponding requirements for the cohort or phase of the study into which they will enroll:
Dose-escalation Phase: Subjects with advanced solid tumors (any tumor type) considered to have no standard-of care treatment for their malignancy with a curative intent, either as initial therapy or after progressing to prior therapies; subjects who have been treated previously with a CSF1R inhibitor or an anti PD1/PDL1 inhibitor may enroll.
Expansion Phase: Subjects with 1 of the tumor types who have relapsed from or are refractory to standard treatment. Subjects with non-small-cell lung cancer (non-squamous; EGFR, ALK wild type), advanced melanoma, ovarian cancer, unresectable RCC with component of clear-cell histology and/or component of sarcomatoid histology, glioblastoma or gliosarcoma, gastrointestinal stromal tumor.
Subjects with melanoma must have a histologically confirmed diagnosis of stage III disease not amenable to local therapy. Melanoma subjects may have received any number of prior lines of therapy for metastatic disease and must have measurable disease per RECISTv1.1. Subjects with melanoma who have received prior treatment with a BRAF/MEK inhibitor are acceptable candidates.

Key exclusion criteria (31 listed)

A subject who meets any of the following criteria will be disqualified from entering the study:
Disease that is suitable for local therapy administered with curative intent.
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days prior to the first dose of study treatment.
Has had monoclonal antibody within 28 days of first dose of study treatment or has not recovered from AEs due to agents administered more than 28 days earlier.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PLX3397Also: PexidartinibPLX3397 capsules, 200 mg	Drug	PLX3397 and Pembrolizumab (Part 1), PLX3397 and Pembrolizumab (Part 2)
PembrolizumabAlso: Keytruda, MK-3475, SCH 900475Pembrolizumab, 200 mg, IV	Biological	PLX3397 and Pembrolizumab (Part 1), PLX3397 and Pembrolizumab (Part 2)

Primary outcome

Treatment-emergent Adverse Events (TEAEs) in Participants Regardless of Causality While Taking PLX3397 in Combination With Pembrolizumab
Time frame: 1 year (Dose Escalation); 2 years (Dose Expansion)
Treatment-emergent Adverse Events (TEAEs) in participants regardless of causality while taking PLX3397 in combination with pembrolizumab are reported

1 secondary outcome

Summary of the Percentage of Participants With Objective Response Rate Assessed by RECIST v1.1 During Pembrolizumab and PLX3397
Time frame: 1 year (Dose Escalation); 2 years (Dose Expansion)

Results and safety

Results posted to the registry on 9 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Escalation: 400 mg/Day	4	2
Dose Escalation: 600 mg/Day	3	0
Dose Escalation: 600 mg/Day (Liver Metastases	7	0
Dose Escalation: 600 mg/Day (no Liver Metastases)	9	1
Dose Escalation: 800 mg/Day (Liver Metastases)	4	2
Dose Escalation: 800 mg/Day (no Liver Metastases)	6	5
Dose Expansion: Melanoma	13	3
Dose Expansion: NSCLC	8	4
Dose Expansion: Ovarian Cancer	15	9
Dose Expansion: SCCHN	3	1
Dose Expansion: GIST	6	4

Primary outcome: Treatment-emergent Adverse Events (TEAEs) in Participants Regardless of Causality While Taking PLX3397 in Combination With Pembrolizumab

Time frame: 1 year (Dose Escalation); 2 years (Dose Expansion). Count of participants. Unit: Participants

Measure	Dose Escalation: 400 mg/Day n = 4	Dose Escalation: 600 mg/Day n = 3	Dose Escalation: 600 mg/Day (Liver Metastases n = 7	Dose Escalation: 600 mg/Day (no Liver Metastases) n = 9	Dose Escalation: 800 mg/Day (Liver Metastases) n = 4	Dose Escalation: 800 mg/Day (no Liver Metastases) n = 6	Dose Expansion: Melanoma n = 13	Dose Expansion: NSCLC n = 8	Dose Expansion: Ovarian Cancer n = 15	Dose Expansion: SCCHN n = 3	Dose Expansion: GIST n = 6
Value	4	3	7	9	4	6	12	8	15	3	6

Population analysed: Safety events were assessed in the Safety Population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Escalation: 400 mg/Day	2 of 4 (50%)	4 of 4 (100%)	2 of 4
Dose Escalation: 600 mg/Day	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Dose Escalation: 600 mg/Day (Liver Metastases	3 of 7 (42.9%)	7 of 7 (100%)	2 of 7
Dose Escalation: 600 mg/Day (no Liver Metastases)	3 of 9 (33.3%)	9 of 9 (100%)	6 of 9
Dose Escalation: 800 mg/Day (Liver Metastases)	2 of 4 (50%)	4 of 4 (100%)	2 of 4
Dose Escalation: 800 mg/Day (no Liver Metastases)	3 of 6 (50%)	6 of 6 (100%)	0 of 6
Dose Expansion: Melanoma	3 of 13 (23.1%)	12 of 13 (92.3%)	5 of 13
Dose Expansion: NSCLC	3 of 8 (37.5%)	8 of 8 (100%)	1 of 8
Dose Expansion: Ovarian Cancer	5 of 15 (33.3%)	15 of 15 (100%)	3 of 15
Dose Expansion: SCCHN	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Dose Expansion: GIST	0 of 6 (0%)	6 of 6 (100%)	0 of 6

Limitations and caveats (from the sponsor): Enrollment for this study was terminated early for insufficient evidence of clinical efficacy. Some of the planned statistical analyses described in the protocol and Statistical Analysis Plan (SAP) were not performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https:// vivli.org/ourmember/daiichi-sankyo/

Related trials for Melanoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PLX3397 and Pembrolizumab in people with Melanoma and Non-small Cell Lung Cancer, run by Daiichi Sankyo at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-emergent Adverse Events (TEAEs) in Participants Regardless of Causality While Taking PLX3397 in Combination With Pembrolizumab (time frame: 1 year (Dose Escalation); 2 years (Dose Expansion)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02452424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.