Stage IV MelanomaPhase 1/2NCT02990416
A-dmDT390-bisFv(UCHT1) Fusion Protein With Ionizing Radiation and Pembrolizumab for the Treatment of Stage IV Melanoma
A Phase 1/2 study testing A-dmDT390-bisFv(UCHT1), Pembrolizumab and Ionizing Radiation in people with Stage IV Melanoma, run by Virogen Biotechnology Inc. at 1 site in United States.
Trial summary
This study evaluates the effectiveness of adding a single four-day treatment of the fusion protein A-dmDT390-bisFv(UCHT1) - plus single palliative tumor radiation - with standard of care KEYTRUDA (Pembrolizumab) therapy for the treatment of metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stage IV Melanoma
- What is being tested?
- A-dmDT390-bisFv(UCHT1), Pembrolizumab and Ionizing Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jun 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must have histologically proven stage IV metastatic melanoma consisting of at least two lesions >= 1.5 cm that would not occupy the same radiation field. Patients must be treatment naïve except for treatment with BRAF inhibitors. Patients with melanoma must have an anti-DT titer of <20 μg/ml. Patients with brain metastasis and ocular and mucosal lesions can be enrolled at the discretion of the PI providing that other non-brain and non-ocular metastatic lesions are available as targets for radiation therapy
- Patients must have a performance status of < 2 on Eastern Cooperative Oncology Group scale (see Appendix). Patients must have fully recovered from toxicity of prior therapy with BRAF inhibitors. Adequate bone marrow function will be defined as ANC >750 uL, WBC >1000 uL, platelets >60,000 uL and Hb > 9g/dL
- Patients must have:
- bilirubin < 1.5 mg/dL,
- transaminases < 2.5 X ULN,
- albumin > 3 gm/dL,
Show all 12Show fewer
- creatinine < 2.0 mg/dL,
- adequate pulmonary function by physical exam and pulse oximetry and adequate cardiac reserve (EF > 50% normal).
- Patients must have a normal echocardiogram without any evidence of cardiac chamber hypertrophy, dilatation or hypokinesis. The Sponsor must be provided with copies of these tests before Sponsor will approve enrollment. In addition, the sponsor must receive a list of current medications taken by the patient before Sponsor will approve enrollment.
- Patients must give written informed consent prior to registration (see Informed Consent).
- Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion.
- Patients of ages 18-80 are eligible provided they have stage IV melanoma and are negative for BRAF or have failed BRAF inhibitor treatment or if they have failed or are intolerant to other established therapy known to provide clinical benefit for their condition or if they have been adequately consented and agreed to forgo FDA approved clinically meaningful therapy.
Who cannot join
- Failure to meet any of the criteria set forth in Inclusion Criteria.
- Inability to give informed consent because of psychiatric problems, or complicated medical problems.
- Serious concurrent medical problems, uncontrolled infections, or disseminated intravascular coagulopathy (DIC).
- Preexisting cardiovascular disease, the only exception being well controlled essential hypertension with a sitting B.P. of <155 systolic and <90 diastolic without any evidence of structural heart disease or one episode of myocardial infarction > 8 months ago. A past history of the any of the following are exclusions:
- Congestive heart failure,
- Atrial fibrillation,
Show all 14Show fewer
- Pulmonary hypertension,
- Anticoagulant drug therapy,
- Thromboembolic events,
- Cardiomyopathy or a myocardial infarction within the past 8 months. Referring physicians will be asked to verify that their referred patients do not have these exclusionary histories listed in 3.2 and a copy of this verification must be sent to the Sponsor before the Sponsor will approve of enrollment. Because beta-blockers have been associated with adverse events during anaphylactic reactions and because such reactions can occur with IV infusions of proteins such as the study drug, the sponsor requires that patients receiving beta-blockers for hypertension be converted to another anti-hypertensive reagent 2-3 weeks prior to receiving the study drug. Angiotensin inhibitors, angiotensin receptor blockers and calcium channel blockers are all acceptable.
- Pregnant or nursing women will be excluded from study.
- History of congestive heart failure.
- History of cirrhosis of the liver.
- Prior treatment with alemtuzumab (Campath) or similar agents or procedures that depress blood T cell counts to below 50% of the lower limit of normal.
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: Phase I/II Trial of the A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation and Pembrolizumab for the Treatment of Stage IV Melanoma
This study evaluates the effectiveness of adding a single four-day treatment of the fusion protein A-dmDT390-bisFv(UCHT1) - plus single palliative tumor radiation - with standard of care KEYTRUDA (Pembrolizumab) therapy for the treatment of metastatic melanoma. The results will be measured by comparing the combined therapy to historical data of KEYTRUDA alone.
Read the detailed description
The purpose of this trial is to test the hypothesis that A-dmDT390-bisFv(UCHT1) can act as an immunomodulator of late stage metastatic melanoma when combined with palliative radiation (to induce the priming of activated T cells with tumor antigens) and Pembrolizumab.
A-dmDT390-bisFv(UCHT1), an anti-T cell immunotoxin is currently being studied as a treatment for cutaneous T cell lymphoma and other CD3+ malignant diseases (NCT00611208 and NCT02943642). During the course of this study, data accumulated that A-dmDT390-bisFv(UCHT1) could be acting as an immunomodulator. This was based on the observation that four out of six partial responses converted to complete responses at times ranging between 6 and 24 months following the completion of the 4-day treatment protocol (serum half life ~45 min.) and no other treatment took place. Complete response durations were 4-6+ years.
Checkpoint inhibitors have revolutionized the treatment of certain solid tumors, notably melanoma, NSCLC and renal cancer. Yet the overall response rate remains low and the mechanisms limiting responses have not been elucidated.
Based on the findings that checkpoint inhibitors have higher response rates when the tumor neoantigen burden is higher (over 1 mutation per megabase, Shumacher \& Schreiber, 2015) the investigators propose to increase the neoantigen burden by combining two distinct manipulations:
- Treatment with an anti-CD3 fusion protein Resimmune days 1-4 to induce a 20-fold increase in CD8+ central memory T cells and
- Treatment with anti-PD1 day 16 and q. 3 weeks to block PD-1/PD-L1 negative regulation on the newly activated T cells (Blake et al., 2015) and to block high levels of PD-1 in the tumor microenvironment (Ahmadzadeh et al., 2009).
Palliative tumor radiation day 5 will provide the tumor antigen release needed to convert the expanded central memory T cells to effector memory T cells.
The study will be a single-arm, uncontrolled phase I/II trial to estimate the safely of the combined treatment and then estimate the efficacy in terms of RECIST 1.1 in patients with stage Stage IV metastatic melanoma. The primary endpoint is the clinical response as defined by progression-free survival (PFS). The second end point will be tolerability to treatment. Secondary end points to be considered are overall survival (OS).
The study is conducted in 2 phases. In phase I (safety), the investigators will enroll 6 patients. In first stage, 25 total patients will be enrolled. Using Simon's two stage minimax design for phase II trials, the investigators plan to enroll a maximum of 63 patients.
- Conditions
- Stage IV Melanoma
- Being tested
- A-dmDT390-bisFv(UCHT1), Pembrolizumab, Ionizing Radiation
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-dmDT390-bisFv(UCHT1)Biological
Also called Resimmune® (proposed marketing designation)
anti-T cell immunotoxin (antibody targeting CD3 on T-cells tagged with diphtheria toxin without binding domain)
PembrolizumabBiological
Also called KEYTRUDA
A humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities.
Ionizing RadiationRadiation
Electromagnetic or corpuscular radiation capable of producing ions, directly or indirectly, in its passage through matter.
| Study group | Role | What they receive |
|---|---|---|
| A-dmDT390-bisFv(UCHT1)/Radiation/Pembrolizumab | Experimental | A-dmDT390-bisFv(UCHT1): 2.5 µg/kg 2x x 4 days, Ionizing Radiation: single treatment on day five of 14-24 Gy to a tumor, Pembrolizumab: 2 mg/kg IV every 3 weeks Receives: Biological: A-dmDT390-bisFv(UCHT1); Biological: Pembrolizumab; Radiation: Ionizing Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response primary outcome measure is the change in Progression Free Survival time (PFS).
The PFS time will be determined as the time from enrollment until the first adverse event (i.e., disease progression or death due to any cause).
Measured: 2 months, then at least every 3 months post treatment or until disease progression (maximum 36 months)
Secondary outcomes (3)
Changes in Clinical Response Rates
Changes in clinical response rates (complete, partial, and sustained) along with 95% estimated confidence intervals compared to the historical record of Pembrolizumab and local palliative radiation. Disease progression and efficacy response will be determined using RECIST 1.1. At a minimum, CT scans of the chest, abdomen, and pelvis will be performed at study entry, at 2 months, and, if a response or stable disease, at least every 3 months (±7 days) for up to 1 year after the last dose of study drug, and/or at any time there is clinical evidence of disease progression, to evaluate disease status (assessed up to 36 months).
Measured: 2 months, then at least every 3 months post treatment or until disease progression (maximum 36 months)
Tolerability to Treatment
Determine the tolerability of A-dmDT390-bisFv(UCHT1) at a total dose of 20 μg/kg when combined with Pembrolizumab and local palliative radiation towards metastatic lesions in stage IV melanoma as a percentage of patients experiencing serious adverse events. The cumulative number of CTCAE grade 3 or 4 toxic events either from lab data or clinical findings will be monitored. Multiple measurements will be aggregated to arrive at one reported value (e.g., Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment).
Measured: 2 months, then at least every 3 months post treatment or until disease progression (maximum 36 months)
Overall Survival, OS
The OS time will be determined as the time from enrollment until death or last follow-up evaluation, assessed up to 36 months.
Measured: 2 months, then at least every 3 months post treatment (maximum 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionFeb 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stage IV MelanomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virogen Biotechnology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Sponsor
- Investigators
- Jason Chesney, MD, PhD, Principal investigator, James Graham Brown Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990416
- Sponsor's protocol ID
- FDA IND 118558
- Status last verified
- Dec 2016
- First submitted
- 28 Nov 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Schumacher TN, Schreiber RD. Neoantigens in cancer immunotherapy. Science. 2015 Apr 3;348(6230):69-74. doi: 10.1126/science.aaa4971.
PubMed 25838375Blake SJ, Ching AL, Kenna TJ, Galea R, Large J, Yagita H, Steptoe RJ. Blockade of PD-1/PD-L1 promotes adoptive T-cell immunotherapy in a tolerogenic environment. PLoS One. 2015 Mar 5;10(3):e0119483. doi: 10.1371/journal.pone.0119483. eCollection 2015.
PubMed 25741704Ahmadzadeh M, Johnson LA, Heemskerk B, Wunderlich JR, Dudley ME, White DE, Rosenberg SA. Tumor antigen-specific CD8 T cells infiltrating the tumor express high levels of PD-1 and are functionally impaired. Blood. 2009 Aug 20;114(8):1537-44. doi: 10.1182/blood-2008-12-195792. Epub 2009 May 7.
PubMed 19423728Frankel AE, Woo JH, Ahn C, Foss FM, Duvic M, Neville PH, Neville DM. Resimmune, an anti-CD3epsilon recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma. Haematologica. 2015 Jun;100(6):794-800. doi: 10.3324/haematol.2015.123711. Epub 2015 Mar 20.
PubMed 25795722
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of the A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation and Pembrolizumab for the Treatment of Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT02990416
- Acronym / sponsor ID
- FDA IND 118558
- Conditions
- Stage IV Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Virogen Biotechnology Inc.Industry (pharma, biotech, devices)
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Jan 2017
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of adding a single four-day treatment of the fusion protein A-dmDT390-bisFv(UCHT1) - plus single palliative tumor radiation - with standard of care KEYTRUDA (Pembrolizumab) therapy for the treatment of metastatic melanoma. The results will be measured by comparing the combined therapy to historical data of KEYTRUDA alone.
Detailed description
The purpose of this trial is to test the hypothesis that A-dmDT390-bisFv(UCHT1) can act as an immunomodulator of late stage metastatic melanoma when combined with palliative radiation (to induce the priming of activated T cells with tumor antigens) and Pembrolizumab.
A-dmDT390-bisFv(UCHT1), an anti-T cell immunotoxin is currently being studied as a treatment for cutaneous T cell lymphoma and other CD3+ malignant diseases (NCT00611208 and NCT02943642). During the course of this study, data accumulated that A-dmDT390-bisFv(UCHT1) could be acting as an immunomodulator. This was based on the observation that four out of six partial responses converted to complete responses at times ranging between 6 and 24 months following the completion of the 4-day treatment protocol (serum half life ~45 min.) and no other treatment took place. Complete response durations were 4-6+ years.
Checkpoint inhibitors have revolutionized the treatment of certain solid tumors, notably melanoma, NSCLC and renal cancer. Yet the overall response rate remains low and the mechanisms limiting responses have not been elucidated.
Based on the findings that checkpoint inhibitors have higher response rates when the tumor neoantigen burden is higher (over 1 mutation per megabase, Shumacher \& Schreiber, 2015) the investigators propose to increase the neoantigen burden by combining two distinct manipulations:
- Treatment with an anti-CD3 fusion protein Resimmune days 1-4 to induce a 20-fold increase in CD8+ central memory T cells and
- Treatment with anti-PD1 day 16 and q. 3 weeks to block PD-1/PD-L1 negative regulation on the newly activated T cells (Blake et al., 2015) and to block high levels of PD-1 in the tumor microenvironment (Ahmadzadeh et al., 2009).
Palliative tumor radiation day 5 will provide the tumor antigen release needed to convert the expanded central memory T cells to effector memory T cells.
The study will be a single-arm, uncontrolled phase I/II trial to estimate the safely of the combined treatment and then estimate the efficacy in terms of RECIST 1.1 in patients with stage Stage IV metastatic melanoma. The primary endpoint is the clinical response as defined by progression-free survival (PFS). The second end point will be tolerability to treatment. Secondary end points to be considered are overall survival (OS).
The study is conducted in 2 phases. In phase I (safety), the investigators will enroll 6 patients. In first stage, 25 total patients will be enrolled. Using Simon's two stage minimax design for phase II trials, the investigators plan to enroll a maximum of 63 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A-dmDT390-bisFv(UCHT1)/Radiation/Pembrolizumab | Experimental | Biological: A-dmDT390-bisFv(UCHT1), Biological: Pembrolizumab, Radiation: Ionizing RadiationA-dmDT390-bisFv(UCHT1): 2.5 µg/kg 2x x 4 days, Ionizing Radiation: single treatment on day five of 14-24 Gy to a tumor, Pembrolizumab: 2 mg/kg IV every 3 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- All patients must have histologically proven stage IV metastatic melanoma consisting of at least two lesions >= 1.5 cm that would not occupy the same radiation field. Patients must be treatment naïve except for treatment with BRAF inhibitors. Patients with melanoma must have an anti-DT titer of <20 μg/ml. Patients with brain metastasis and ocular and mucosal lesions can be enrolled at the discretion of the PI providing that other non-brain and non-ocular metastatic lesions are available as targets for radiation therapy
- Patients must have a performance status of < 2 on Eastern Cooperative Oncology Group scale (see Appendix). Patients must have fully recovered from toxicity of prior therapy with BRAF inhibitors. Adequate bone marrow function will be defined as ANC >750 uL, WBC >1000 uL, platelets >60,000 uL and Hb > 9g/dL
- Patients must have:
- Patients must have a normal echocardiogram without any evidence of cardiac chamber hypertrophy, dilatation or hypokinesis. The Sponsor must be provided with copies of these tests before Sponsor will approve enrollment. In addition, the sponsor must receive a list of current medications taken by the patient before Sponsor will approve enrollment.
- Patients must give written informed consent prior to registration (see Informed Consent).
Key exclusion criteria (14 listed)
- Failure to meet any of the criteria set forth in Inclusion Criteria.
- Inability to give informed consent because of psychiatric problems, or complicated medical problems.
- Serious concurrent medical problems, uncontrolled infections, or disseminated intravascular coagulopathy (DIC).
- Preexisting cardiovascular disease, the only exception being well controlled essential hypertension with a sitting B.P. of <155 systolic and <90 diastolic without any evidence of structural heart disease or one episode of myocardial infarction > 8 months ago. A past history of the any of the following are exclusions:
- Pregnant or nursing women will be excluded from study.
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 |
|---|---|---|
| A-dmDT390-bisFv(UCHT1)Also: Resimmune® (proposed marketing designation)anti-T cell immunotoxin (antibody targeting CD3 on T-cells tagged with diphtheria toxin without binding domain) | Biological | A-dmDT390-bisFv(UCHT1)/Radiation/Pembrolizumab |
| PembrolizumabAlso: KEYTRUDAA humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities. | Biological | A-dmDT390-bisFv(UCHT1)/Radiation/Pembrolizumab |
| Ionizing RadiationElectromagnetic or corpuscular radiation capable of producing ions, directly or indirectly, in its passage through matter. | Radiation | A-dmDT390-bisFv(UCHT1)/Radiation/Pembrolizumab |
Primary outcome
Clinical Response primary outcome measure is the change in Progression Free Survival time (PFS).
Time frame: 2 months, then at least every 3 months post treatment or until disease progression (maximum 36 months)
The PFS time will be determined as the time from enrollment until the first adverse event (i.e., disease progression or death due to any cause).
3 secondary outcomes
Changes in Clinical Response Rates
Time frame: 2 months, then at least every 3 months post treatment or until disease progression (maximum 36 months)
Tolerability to Treatment
Time frame: 2 months, then at least every 3 months post treatment or until disease progression (maximum 36 months)
Overall Survival, OS
Time frame: 2 months, then at least every 3 months post treatment (maximum 36 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Background: PubMed 25838375Schumacher TN, Schreiber RD. Neoantigens in cancer immunotherapy. Science. 2015 Apr 3;348(6230):69-74. doi: 10.1126/science.aaa4971.
- Background: PubMed 25741704Blake SJ, Ching AL, Kenna TJ, Galea R, Large J, Yagita H, Steptoe RJ. Blockade of PD-1/PD-L1 promotes adoptive T-cell immunotherapy in a tolerogenic environment. PLoS One. 2015 Mar 5;10(3):e0119483. doi: 10.1371/journal.pone.0119483. eCollection 2015.
- Background: PubMed 19423728Ahmadzadeh M, Johnson LA, Heemskerk B, Wunderlich JR, Dudley ME, White DE, Rosenberg SA. Tumor antigen-specific CD8 T cells infiltrating the tumor express high levels of PD-1 and are functionally impaired. Blood. 2009 Aug 20;114(8):1537-44. doi: 10.1182/blood-2008-12-195792. Epub 2009 May 7.
- Results publication: PubMed 25795722Frankel AE, Woo JH, Ahn C, Foss FM, Duvic M, Neville PH, Neville DM. Resimmune, an anti-CD3epsilon recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma. Haematologica. 2015 Jun;100(6):794-800. doi: 10.3324/haematol.2015.123711. Epub 2015 Mar 20.
- Individual participant dataSharing planned: Undecided
Related trials for Stage IV Melanoma
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 1/2
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Unresectable or Metastatic Melanoma
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
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.
Jason Chesney, MD, PhD principal investigator
James Graham Brown Cancer
1 site 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 A-dmDT390-bisFv(UCHT1), Pembrolizumab and Ionizing Radiation in people with Stage IV Melanoma, run by Virogen Biotechnology Inc. at 1 site 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 12 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brown Cancer Center Clinical Trials Office (502-562-3429, ctobcc@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response primary outcome measure is the change in Progression Free Survival time (PFS). (time frame: 2 months, then at least every 3 months post treatment or until disease progression (maximum 36 months)). 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 NCT02990416, which also lists 4 linked publications.
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 13 Dec 2016.