MelanomaPhase 1NCT02696356
Phase 1 Study of GRN-1201 in HLA-A*02 Subjects With Resected Melanoma
A Phase 1 study testing GRN-1201 in people with Melanoma, run by BrightPath Biotherapeutics at 4 sites in United States.
Trial summary
This is a study of an investigational cancer vaccine called GRN-1201. Treatment with the GRN-1201 vaccine is a type of immunotherapy. The goal of immunotherapy is to stimulate the body's immune system (white blood cells) to attack cancer cells and kill them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- GRN-1201
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2016to Mar 2018
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥18 years of age (at the time consent is obtained);
- Provide written informed consent for study participation, approved by the appropriate institutional review board (IRB), and be willing and able to cooperate with all aspects of the protocol;
- Resected, histologically proven, cutaneous melanoma determined to be Stage IIb, IIc, or III; according to the American Joint Commission of Cancer Staging, 7th edition
- Human leukocyte antigen (HLA)-A*02+ by serology by an ASHI accredited laboratory;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0;
- Female subjects must have a negative serum human chorionic gonadotropic (hCG) test (pregnancy test not required for subjects with bilateral oophorectomy and/or hysterectomy or for those subjects who are >1 year post-menopausal); and
- All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 3 months after the last dose of study drug.
Who cannot join
- Inadequate hematologic or biologic function as determined by the following laboratory tests:
- Hemoglobin <10 g/dL,
- Platelet count <100,000/µL,
- Leukocyte count <3000/µL,
- Lymphocyte count <1000/µL,
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >2 × upper limit of normal (ULN),
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- Total bilirubin >ULN: Subjects with Gilbert's syndrome are allowed if total bilirubin is <3.0 mg/dL and direct bilirubin is ≤ULN,
- Serum creatinine >ULN, or Prothrombin time (PT) or international normalized ratio (INR) >1.5 × ULN or activated partial thromboplastin time (aPTT) > 1.5 × ULN
- Greater than 3 months since melanoma resection;
- Have known fungal, bacterial, and/or viral infection, including human immunodeficiency virus (HIV) or hepatitis virus (B or C);
- Active immunosuppressive therapy associated with: Organ or allogeneic hematopoietic stem cell transplant, High-dose steroids, such as daily steroid doses in excess of 20 mg/day of prednisone (Note: Use of intra-articular or topical corticosteroids or eye drops containing corticosteroids is acceptable.), or Inhaled corticosteroids;
- Known history of autoimmune conditions including, but not limited to: rheumatoid arthritis, multiple sclerosis, lupus erythematosus, scleroderma, sarcoidosis, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis;
- Current requirement for anti-coagulation therapy that prolongs PT or aPTT 7. History of prior malignancy except: Curatively treated non-melanoma skin cancer; Solid tumor treated curatively >5 years previously without evidence of recurrence; or History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect (e.g., superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast);
- Non-healed wound;
- Prior adjuvant therapy for current melanoma diagnosis;
- History of any clinically significant cardiovascular disorder (i.e., symptoms above Class II per New York Heart Association [NYHA] Functional Classification);
- History of serious allergic reaction to yeast or yeast-derived products, including known or suspected hypersensitivity reaction to sargramostim;
- Pregnant, breastfeeding, or planning to become pregnant during the study;
- Received any other investigational therapy within 28 days of Day 1; or
- Any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Christ Hospital Cancer Research
Cincinnati, Ohio, 45219
University of Pittsburg
Pittsburgh, Pennsylvania, 15232
Providence Health and Services, Providence Portland Medical Center
Portland, Oregon, 97213
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: A Phase 1, Open-Label, Multi-Center, Multi-Dose Study of Intradermal GRN-1201 in HLA-A*02 Subjects With Resected Stage IIb, IIc or III Melanoma
This is a study of an investigational cancer vaccine called GRN-1201. Treatment with the GRN-1201 vaccine is a type of immunotherapy. The goal of immunotherapy is to stimulate the body's immune system (white blood cells) to attack cancer cells and kill them. GRN-1201 consists of 4 different peptides (small parts of proteins) that are expressed by melanoma cells. The intent of treatment with GRN-1201 is to increase your body's immune response to melanoma.
To further increase your body's immune response against tumor cells, the GRN-1201 vaccine will be mixed with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF, also known as sargramostim). GM-CSF is a man-made protein that helps stimulate the immune system and increase the response against the tumor cells. This is a phase I study which means that this will be the first time GRN-1201 is given in combination with GM-CSF to humans. It will be tested in a small number of people to evaluate its safety, find a safe dose, and identify side effects. The safety of GRN-1201 will be tested at three different doses; the GM-CSF dose will remain the same.
Read the detailed description
GRN-1201 is a novel HLA-A*02-restricted multiple-peptide, therapeutic cancer vaccine, being developed by GreenPeptide for the treatment of melanoma because it can induce immune responses against tumor associated antigens (TAAs), particularly cytotoxic T cell (CTL) responses. Granulocyte-macrophage-colony-stimulating-factor (GM-CSF) (Leukine®, SanofiAventis) will be administered in combination with GRN-1201 as an immuno-adjuvant
In contrast to advanced melanoma, treatment options in the adjuvant setting are limited. Surgical resection is the primary treatment of Stage IIb, IIc, and III melanoma patients. The rate of disease recurrence in patients with American Joint Committee on Cancer (AJCC) TNM Stage II (T2-4N0M0) and Stage III (TanyN+M0) disease ranges between 20 -60%, with 5-year overall survival between 45 - 70%. Thus, safe and effective treatment options to reduce the risk of recurrence are much needed. Considering their generally safe nature, peptide-based cancer vaccines would be ideal to address this unmet medical need. Patients with Stage IIb, IIc or III melanoma are, in general, healthy following local therapy. They are anticipated to maintain an immune system uncompromised by chemotherapy or disease burden. Further, they may have already developed immune response to TAAs targeted by GRN-1201, which may increase the probability of developing effective immune responses. It is conceivable that the combination of peptide vaccines with an immune checkpoint inhibitor, especially with a PD-1 pathway inhibitor, could enhance the efficacy of immunotherapy without increasing toxicity. Studies evaluating the combination of a melanoma vaccine with nivolumab in advanced melanoma [14] and resected high-risk metastatic melanoma patients [15] reported encouraging clinical outcome.
The pre-clinical data suggest that GRN-1201 may have anti-tumor activity in the adjuvant setting or may enhance activity of other drugs such as checkpoint inhibitors in the adjuvant or metastatic disease setting, by enhancing immune responses against TAAs.
- Conditions
- Melanoma
- Being tested
- GRN-1201
- Keywords
- HLA-A*02
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRN-1201Biological
GRN-1201 is a vaccine comprised of 4 peptides
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 0.1mg GRN-1201 Receives: Biological: GRN-1201 |
| Cohort 2 | Active comparator | 1.0mg GRN-1201 Receives: Biological: GRN-1201 |
| Cohort 3 | Experimental | 3.0mg GRN-1201 Receives: Biological: GRN-1201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0,
Measured: First dose through 16 weeks after last dose of study drug
Secondary outcomes (1)
Immune response by gamma interferon ElliSpot assay
Measured: First dose through 16 weeks after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrightPath Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walter J Urba, MD, PhD, Principal investigator, Providence Health and Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696356
- Sponsor's protocol ID
- GRN1201-001
- Status last verified
- Jun 2018
- First submitted
- 3 Feb 2016
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multi-Center, Multi-Dose Study of Intradermal GRN-1201 in HLA-A*02 Subjects With Resected Stage IIb, IIc or III Melanoma
- ClinicalTrials.gov ID
- NCT02696356
- Acronym / sponsor ID
- GRN1201-001
- Conditions
- Melanoma
- Keywords
- HLA-A*02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- BrightPath BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 2 Mar 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 is a study of an investigational cancer vaccine called GRN-1201. Treatment with the GRN-1201 vaccine is a type of immunotherapy. The goal of immunotherapy is to stimulate the body's immune system (white blood cells) to attack cancer cells and kill them. GRN-1201 consists of 4 different peptides (small parts of proteins) that are expressed by melanoma cells. The intent of treatment with GRN-1201 is to increase your body's immune response to melanoma.
To further increase your body's immune response against tumor cells, the GRN-1201 vaccine will be mixed with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF, also known as sargramostim). GM-CSF is a man-made protein that helps stimulate the immune system and increase the response against the tumor cells. This is a phase I study which means that this will be the first time GRN-1201 is given in combination with GM-CSF to humans. It will be tested in a small number of people to evaluate its safety, find a safe dose, and identify side effects. The safety of GRN-1201 will be tested at three different doses; the GM-CSF dose will remain the same.
Detailed description
GRN-1201 is a novel HLA-A*02-restricted multiple-peptide, therapeutic cancer vaccine, being developed by GreenPeptide for the treatment of melanoma because it can induce immune responses against tumor associated antigens (TAAs), particularly cytotoxic T cell (CTL) responses. Granulocyte-macrophage-colony-stimulating-factor (GM-CSF) (Leukine®, SanofiAventis) will be administered in combination with GRN-1201 as an immuno-adjuvant
In contrast to advanced melanoma, treatment options in the adjuvant setting are limited. Surgical resection is the primary treatment of Stage IIb, IIc, and III melanoma patients. The rate of disease recurrence in patients with American Joint Committee on Cancer (AJCC) TNM Stage II (T2-4N0M0) and Stage III (TanyN+M0) disease ranges between 20 -60%, with 5-year overall survival between 45 - 70%. Thus, safe and effective treatment options to reduce the risk of recurrence are much needed. Considering their generally safe nature, peptide-based cancer vaccines would be ideal to address this unmet medical need. Patients with Stage IIb, IIc or III melanoma are, in general, healthy following local therapy. They are anticipated to maintain an immune system uncompromised by chemotherapy or disease burden. Further, they may have already developed immune response to TAAs targeted by GRN-1201, which may increase the probability of developing effective immune responses. It is conceivable that the combination of peptide vaccines with an immune checkpoint inhibitor, especially with a PD-1 pathway inhibitor, could enhance the efficacy of immunotherapy without increasing toxicity. Studies evaluating the combination of a melanoma vaccine with nivolumab in advanced melanoma [14] and resected high-risk metastatic melanoma patients [15] reported encouraging clinical outcome.
The pre-clinical data suggest that GRN-1201 may have anti-tumor activity in the adjuvant setting or may enhance activity of other drugs such as checkpoint inhibitors in the adjuvant or metastatic disease setting, by enhancing immune responses against TAAs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: GRN-12010.1mg GRN-1201 |
| Cohort 2 | Active comparator | Biological: GRN-12011.0mg GRN-1201 |
| Cohort 3 | Experimental | Biological: GRN-12013.0mg GRN-1201 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females ≥18 years of age (at the time consent is obtained);
- Provide written informed consent for study participation, approved by the appropriate institutional review board (IRB), and be willing and able to cooperate with all aspects of the protocol;
- Resected, histologically proven, cutaneous melanoma determined to be Stage IIb, IIc, or III; according to the American Joint Commission of Cancer Staging, 7th edition
- Human leukocyte antigen (HLA)-A*02+ by serology by an ASHI accredited laboratory;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0;
Key exclusion criteria (20 listed)
- Inadequate hematologic or biologic function as determined by the following laboratory tests:
- Hemoglobin <10 g/dL,
- Platelet count <100,000/µL,
- Leukocyte count <3000/µL,
- Lymphocyte count <1000/µL,
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 |
|---|---|---|
| GRN-1201GRN-1201 is a vaccine comprised of 4 peptides | Biological | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Summary of number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0,
Time frame: First dose through 16 weeks after last dose of study drug
1 secondary outcome
Immune response by gamma interferon ElliSpot assay
Time frame: First dose through 16 weeks after last dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Walter J Urba, MD, PhD principal investigator
Providence Health and Services
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GRN-1201 in people with Melanoma, run by BrightPath Biotherapeutics at 4 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 7 inclusion and 20 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: finished, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Summary of number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, (time frame: First dose through 16 weeks after last dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2018.