Metastatic NSCLCPhase 2NCT03417882
GRN-1201 With Pembrolizumab in Subjects With Metastatic PD-L1+ NSCLC
A Phase 2 study testing GRN-1201 + Pembrolizumab in people with Metastatic NSCLC, run by BrightPath Biotherapeutics at 11 sites in United States.
Trial summary
This is a non-randomized, Phase 2, 2-stage, open-label, multi-center study of GRN-1201/sargramostim + pembrolizumab in subjects with PD-L1+ metastatic NSCLC. All subjects will have newly diagnosed metastatic PD-L1+ (TPS ≥ 50%) NSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic NSCLC
- What is being tested?
- GRN-1201 + Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 11 sitesUnited States
- Study dates
- 3 Jan 2019to 5 Dec 2022
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be male or female at least 18 years of age (at the time consent is obtained);
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);
- Have histologically- or cytologically-confirmed diagnosis of Stage IV NSCLC Have newly diagnosed, metastatic NSCLC with PD-L1 TPS ≥ 50% (as determined by central lab using the 22C3 pharmDx kit) Note: Subjects with documentation of PD-L1 TPS ≥50% by IHC analysis using the 22C3 pharmDx kit will not require repeat PD-L1 testing by central laboratory and
- Have no prior systemic chemotherapy for metastatic disease: at least 6 months since prior adjuvant chemotherapy
- Be HLA-A*02+ as determined by Central Laboratory;
- Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy;
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- Have a life expectancy of at least 3 months;
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team. Target tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions;
- Has adequate organ function as defined by:
- Absolute neutrophil count ≥ 1,500/µL
- Platelets ≥ 100,000/µL
- Hemoglobin ≥ 9 g/dL (without transfusion for at least one month)
- Serum creatinine ≤ 1.5 x Upper Limit of Normal (ULN) OR
- o glomerular filtration rate (GFR) ≥30mL/min if serum creatinine > 1.5 x ULN, creatinine clearance may be calculated using the institutional/laboratory standard method
- Serum total bilirubin ≤ 1.5 x ULN OR
- o Direct bilirubin ≤ ULN for subjects with total bilirubin >1.5 x ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver metastases)
- Albumin ≥2.5mg/dL
- International Normalized Ratio (INR) or PT/aPTT <1.5 x ULN. For subjects receiving anticoagulation therapy, PT/aPTT and INR should not be greater than the recommended range for the intended use of the anticoagulant
- Have recovered from the effects of any prior radiotherapy or surgery;
- Female subjects of childbearing potential must have a negative serum human chorionic gonadotropic (hCG) test within 1 week of Day 1 (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 4 months after the last dose of study treatment.
Who cannot join
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 14 days of the first dose of treatment;
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy > 10 mg prednisone or equivalent per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment;
- Has undergone major surgery within 3 weeks of Study Day 1, Subject must have recovered adequately from any toxicity and/or complications from the intervention prior to starting therapy;
- Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], GM-CSF or recombinant erythropoietin) within 4 weeks prior to study Day 1;
- Has known active central nervous system (CNS) metastases NOTE: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [using the identical imaging modality for each assessment, either magnetic resonance imaging (MRI) or computerized tomography (CT) scan] for at least four weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study treatment;
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- Has carcinomatous meningitis;
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study;
- Has history of interstitial lung disease, or history of (non-infectious) pneumonitis that required steroids, or current pneumonitis;
- Has an active infection requiring systemic therapy NOTE: Antibiotic therapy must have been completed a minimum of 3 days prior to start of study treatment;
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected);
- History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 6 months prior to day 1 of study treatment;
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator;
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study;
- Has received a live virus vaccine within 30 days of the planned first dose of study therapy NOTE: seasonal influenza vaccines for injection which are generally inactivated flu vaccines are permitted; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not permitted;
- Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment; or
- Has 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.
- Have an EGFR or ALK genomic tumor aberrations for which targeted therapy with an EGFR or ALK inhibitor is indicated.
- Additional Exclusion Criteria for Cohort 2:
- Has had prior treatment with an anti-PD-1 or anti-PD-L1 antibody, anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab) or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Robert H Lurie Cancer Center at Northwestern University
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60612
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Norton Healthcare Cancer Institute
Louisville, Kentucky, 40202
East Jefferson General Hospital
Metairie, Louisiana, 70006
Ocshner Cancer Institute
New Orleans, Louisiana, 70121
St Joseph Hospital of Orange
Orange, California, 92868
Florida Hosptial Cancer Center- AdventHealth
Orlando, Florida, 32804
Virginia Cancer Institute
Richmond, Virginia, 23230
Orchard Healthcare
Skokie, Illinois, 60077
About this study
Official title: A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects With Non-Small Cell Lung Cancer With High PD-L1 Expression
This is a non-randomized, Phase 2, 2-stage, open-label, multi-center study of GRN-1201/sargramostim + pembrolizumab in subjects with PD-L1+ metastatic NSCLC. All subjects will have newly diagnosed metastatic PD-L1+ (TPS ≥ 50%) NSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Subjects with EGFR or ALK genomic tumor aberrations with progression on FDA-approved therapy for these aberrations are eligible
Read the detailed description
This is a non-randomized, Phase 2, 2-stage, open-label, multi-center study of GRN-1201/sargramostim + pembrolizumab in subjects with metastatic PD-L1+ NSCLC.
All subjects will have newly diagnosed metastatic PD-L1+ (TPS ≥ 50%) NSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
The study will follow a Simon two-stage design with up to 64 total subjects enrolled. All subjects will receive GRN-1201 at 3.0 mg in combination with 75 µg sargramostim and 200 mg pembrolizumab.
GRN-1201 is to be administered once weekly for 4 weeks followed by every 3-week dosing for an additional 12 doses (16 total doses of GRN-1201). Each dose of GRN-1201 will be given as 1 mL divided into 4 separate 0.25 mL intradermal injections on each day of treatment. Pembrolizumab is to be given every 3 weeks for up to a total of 35 doses.
This study will consist of a screening period of up to 28 days; a treatment period consisting of GRN-1201/sargramostim administered weekly for 4 weeks (4 doses) followed by administration every 3 weeks for 12 additional doses . Pembrolizumab is to be given every 3 weeks for up to a total of 35 doses.
A follow up visit will occur approximately 4 weeks after the last administration of treatment for the study. In addition, all subjects will be followed for evaluation of disease progression and survival
- Conditions
- Metastatic NSCLC
- Being tested
- GRN-1201 + Pembrolizumab
- Keywords
- PD-L1+
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRN-1201 + PembrolizumabBiological
Also called Pembrolizumab
GRN-1201 will be administered in combination with Pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | All subjects will have newly diagnosed, metastatic PD-L1+ (TPS ≥ 50%) NSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Receives: Biological: GRN-1201 + Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect, as measured by response rate of the addition of GRN-1201 to Pembrolizumab
Tumor assessment over time using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: First dose through 16 weeks after last dose of study drug
Secondary outcomes (7)
Evaluate the adverse event profile for the combination of GRN-1201 and Pembrolizumab as assessed by treatment -related events according to CTCAE version 4
The safety and tolerability of GRN-1201/sargramostim + pembrolizumab will be evaluated by local and systemic signs and symptoms of injection site reactions, and incidence of adverse events including immune related adverse events (irAEs).
Measured: First dose through 16 weeks after last dose of study drug
Host immune response to GRN-1201
Immune responses to GRN-1201 will be monitored to establish proof-of principle for the proposed pharmacological effect and demonstrate immunogenicity of GRN-1201.
Immune response to the individual peptides will be assessed by measurement of cytotoxic T lymphocytes (CTLs) (by gamma interferon [IFN-γ] ELISPOT assay) and by measurement of antibodies to each peptide
Measured: First dose through 16 weeks after last dose of study drug
Clinical Benefit response rate (CR + PR + SD >/= 16 weeks)
Tumor assessment over time using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: First dose through 16 weeks after last dose of study drug
Progression-free survival
Progression-free survival will be determined by tumor assessments or death from any cause
Measured: First dose through 2 years after last dose of combination treatment
Duration of response in responding subjects
The duration of objective response will be assessed
Measured: First dose through 16 weeks after last dose of study drug
Duration of clinical benefit
The duration of clinical benefit response rate will be assessed
Measured: First dose through 16 weeks after last dose of study drug
Overall survival
All subjects will be followed for overall survival after discontinuation of combination treatment
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 posted31 Jan 2018
- Study start3 Jan 2019
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Why it stopped: Recruitment rate too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic NSCLCStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will follow a Simon two-stage design \[1\] with up to 64 subjects enrolled. All subjects will receive GRN-1201 at a dose of 3.0 mg per peptide in combination with 75 µg sargramostim (Leukine®) and 200 mg pembrolizumab.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrightPath Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417882
- Sponsor's protocol ID
- GRN-1201-002
- Status last verified
- Aug 2023
- First submitted
- 14 Nov 2017
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects With Non-Small Cell Lung Cancer With High PD-L1 Expression
- ClinicalTrials.gov ID
- NCT03417882
- Acronym / sponsor ID
- GRN-1201-002
- Conditions
- Metastatic NSCLC
- Keywords
- PD-L1+
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment rate too slow
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BrightPath BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 31 Jan 2018 (actual)
- 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 non-randomized, Phase 2, 2-stage, open-label, multi-center study of GRN-1201/sargramostim + pembrolizumab in subjects with PD-L1+ metastatic NSCLC. All subjects will have newly diagnosed metastatic PD-L1+ (TPS ≥ 50%) NSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Subjects with EGFR or ALK genomic tumor aberrations with progression on FDA-approved therapy for these aberrations are eligible
Detailed description
This is a non-randomized, Phase 2, 2-stage, open-label, multi-center study of GRN-1201/sargramostim + pembrolizumab in subjects with metastatic PD-L1+ NSCLC.
All subjects will have newly diagnosed metastatic PD-L1+ (TPS ≥ 50%) NSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
The study will follow a Simon two-stage design with up to 64 total subjects enrolled. All subjects will receive GRN-1201 at 3.0 mg in combination with 75 µg sargramostim and 200 mg pembrolizumab.
GRN-1201 is to be administered once weekly for 4 weeks followed by every 3-week dosing for an additional 12 doses (16 total doses of GRN-1201). Each dose of GRN-1201 will be given as 1 mL divided into 4 separate 0.25 mL intradermal injections on each day of treatment. Pembrolizumab is to be given every 3 weeks for up to a total of 35 doses.
This study will consist of a screening period of up to 28 days; a treatment period consisting of GRN-1201/sargramostim administered weekly for 4 weeks (4 doses) followed by administration every 3 weeks for 12 additional doses . Pembrolizumab is to be given every 3 weeks for up to a total of 35 doses.
A follow up visit will occur approximately 4 weeks after the last administration of treatment for the study. In addition, all subjects will be followed for evaluation of disease progression and survival
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will follow a Simon two-stage design [1] with up to 64 subjects enrolled. All subjects will receive GRN-1201 at a dose of 3.0 mg per peptide in combination with 75 µg sargramostim (Leukine®) and 200 mg pembrolizumab.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: GRN-1201 + PembrolizumabAll subjects will have newly diagnosed, metastatic PD-L1+ (TPS ≥ 50%) NSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Be male or female at least 18 years of age (at the time consent is obtained);
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);
- Have histologically- or cytologically-confirmed diagnosis of Stage IV NSCLC Have newly diagnosed, metastatic NSCLC with PD-L1 TPS ≥ 50% (as determined by central lab using the 22C3 pharmDx kit) Note: Subjects with documentation of PD-L1 TPS ≥50% by IHC analysis using the 22C3 pharmDx kit will not require repeat PD-L1 testing by central laboratory and
- Have no prior systemic chemotherapy for metastatic disease: at least 6 months since prior adjuvant chemotherapy
- Be HLA-A*02+ as determined by Central Laboratory;
Key exclusion criteria (20 listed)
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 14 days of the first dose of treatment;
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy > 10 mg prednisone or equivalent per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment;
- Has undergone major surgery within 3 weeks of Study Day 1, Subject must have recovered adequately from any toxicity and/or complications from the intervention prior to starting therapy;
- Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], GM-CSF or recombinant erythropoietin) within 4 weeks prior to study Day 1;
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-1201 + PembrolizumabAlso: PembrolizumabGRN-1201 will be administered in combination with Pembrolizumab | Biological | Cohort 1 |
Primary outcome
Assess the effect, as measured by response rate of the addition of GRN-1201 to Pembrolizumab
Time frame: First dose through 16 weeks after last dose of study drug
Tumor assessment over time using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
7 secondary outcomes
Evaluate the adverse event profile for the combination of GRN-1201 and Pembrolizumab as assessed by treatment -related events according to CTCAE version 4
Time frame: First dose through 16 weeks after last dose of study drug
Host immune response to GRN-1201
Time frame: First dose through 16 weeks after last dose of study drug
Clinical Benefit response rate (CR + PR + SD >/= 16 weeks)
Time frame: First dose through 16 weeks after last dose of study drug
Progression-free survival
Time frame: First dose through 2 years after last dose of combination treatment
Duration of response in responding subjects
Time frame: First dose through 16 weeks after last dose of study drug
Duration of clinical benefit
Time frame: First dose through 16 weeks after last dose of study drug
Overall survival
Time frame: First dose through 16 weeks after last dose of study drug
Results and safety
The study was stopped early (reason given: Recruitment rate too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRN-1201 + Pembrolizumab in people with Metastatic NSCLC, run by BrightPath Biotherapeutics at 11 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 23 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: stopped early, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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?
The study was stopped early (reason given: Recruitment rate too slow). Results are not available in the source record.
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?
Assess the effect, as measured by response rate of the addition of GRN-1201 to Pembrolizumab (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 8 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.