Non-small Cell Lung CancerPhase 1/2NCT02439450
A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer
A Phase 1/2 study testing Viagenpumatucel-L, Nivolumab and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Heat Biologics at 16 sites in United States.
Trial summary
This study will test whether vaccination with viagenpumatucel-L combined with strategies to modulate the immune response is safe for patients with non-small cell lung adenocarcinoma or squamous cell carcinoma for incurable or metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Viagenpumatucel-L, Nivolumab and Pembrolizumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 16 sitesUnited States
- Study dates
- 15 Apr 2015to 4 Nov 2022
- 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
- Non-small cell lung adenocarcinoma or squamous cell carcimona
- At least one site of measurable disease by RECIST 1.1
- Arm 5: Received at least one prior line of therapy, but no more than three prior lines of therapy, for incurable (i.e. unresectable) or metastatic NSCLC. Up to one prior line of FDA-approved checkpoint inhibitor therapy is permitted (must have received at least 4 months of treatment) --OR--
- Arm 6: Received front line immunotherapy (with or without chemotherapy) for incurable or metastatic NSCLC and did not progress clinically or radiographically per RECIST 1.1 at the most recent imaging assessment, and will begin maintenance immunotherapy with standard of care pembrolizumab ± pemetrexed.
- Life expectancy ≥18 weeks
- Arm 5: Disease progression at study entry --OR--
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- Arm 6: Documented Stable Disease, Partial Response, Complete Response (SD/PR/CR) per RECIST 1.1 after a minimum of 9 to 12 weeks of front line immunotherapy (with or without chemotherapy).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Central nervous system (CNS) metastases may be permitted but must be treated and neurologically stable
- Adequate laboratory parameters
- Willing and able to comply with the protocol and sign informed consent
- Female patients who are of childbearing potential and fertile male patients must agree to use an effective form of contraception throughout study participation
- Willing to provide archival or fresh tumor biopsy at Screening, and fresh tumor biopsy at Week 10 when feasible.
- Arm 5: Suitable for treatment with nivolumab per package insert --OR--
- Arm 6: Suitable for front line maintenance treatment with pembrolizumab ± pemetrexed per the current approved package inserts.
Who cannot join
- Arm 5: Received systemic anticancer therapy within 21 days prior to first dose of study drug
- Human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled infections or concurrent illness, unrelated to the tumor, requiring active therapy
- Any condition requiring concurrent systemic immunosuppressive therapy
- Known immunodeficiency disorders, either primary or acquired
- Known leptomeningeal disease
- Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
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- Pregnant or breastfeeding
- Prior participation in a clinical study of viagenpumatucel-L (HS-110)
- Administration of a live vaccine within 30 days prior to first dose of study drug
- Active, known or suspected autoimmune disease
- Significant cardiovascular disease
- Refractory to prior immunotherapy (clinical or radiographic progression after 12 weeks or less of immunotherapy).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
New York Oncology Hematology
Albany, New York, 12206
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, 41101
BRRH Lynn Cancer Institute
Boca Raton, Florida, 33486
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
Cleveland Clinic
Cleveland, Ohio, 44195
Virginia Cancer Specialists
Fairfax, Virginia, 22031
UC San Diego
La Jolla, California, 92093
Horizon Oncology Research
Lafayette, Indiana, 47905
Baptist Health Louisville
Louisville, Kentucky, 40207
Winthrop Hospital
Mineola, New York, 11501
Memorial Cancer Institute
Pembroke Pines, Florida, 33028
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Providence Portland Medical Center
Portland, Oregon, 97213
Rhode Island Hospital
Providence, Rhode Island, 02903
Washington University School of Medicine
St Louis, Missouri, 63110
University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: A Phase 1b/2 Study of Viagenpumatucel-L (HS-110) in Combination With Multiple Treatment Regimens in Patients With Non-Small Cell Lung Cancer (The "DURGA" Trial)
This study will test whether vaccination with viagenpumatucel-L combined with strategies to modulate the immune response is safe for patients with non-small cell lung adenocarcinoma or squamous cell carcinoma for incurable or metastatic disease.
Read the detailed description
This study will test whether vaccination with viagenpumatucel-L combined with strategies to modulate the immune response is safe for patients with non-small cell lung adenocarcinoma or squamous cell carcinoma for incurable or metastatic disease. These methods collectively use the body's immune system to target the patient's own tumor. Immunosuppression hinders that response, and may develop in NSCLC patients in a variety of ways, such as activation of checkpoint pathways in the tumor microenvironment. Drugs that disrupt checkpoint molecule signaling like anti-PD-1 monoclonal antibodies nivolumab, may release this brake on the immune system. Tumor expression of PD-L1 plays an important role in patient response to checkpoint inhibitors; in general, clinical response to checkpoint inhibitors requires tumor expression of PD-L1 and presence of Tumor Infiltrating Lymphocytes (TIL). Combining viagenpumatucel-L with anti-PD-1 agents may enhance the vaccine's anti-tumor activity while prolonging or increasing the efficacy of the checkpoint inhibitor.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Viagenpumatucel-L, Nivolumab, Pembrolizumab, Pemetrexed
- Keywords
- lung, cancer, gp96, vaccine, immunotherapy, Heat Biologics, Nivolumab, checkpoint inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viagenpumatucel-LBiological
Also called HS-110
Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
NivolumabDrug
Also called Opdivo
Nivolumab 240mg IV q2weeks for 18 weeks or until disease progression or unacceptable toxicity. After the completion of 18 weeks of combination therapy, patients may receive either nivolumab dosing schedule listed in the current approved package insert (every 2 weeks or every 4 weeks) per Investigator discretion.
PembrolizumabDrug
Also called Keytruda
The recommended dose of KEYTRUDA (pembrolizumab) is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
PemetrexedDrug
Also called Alimta
The recommended dose of ALIMTA (pemetrexed) when administered with carboplatin and pembrolizumab for the initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 administered as an intravenous infusion over 10 minutes prior to carboplatin on Day 1 of each 21-day cycle for 4 cycles. Pembrolizumab should be administered prior to ALIMTA when given on the same day.
| Study group | Role | What they receive |
|---|---|---|
| Arm 5: Viagenpumatucel-L + Nivolumab CPI Naive | Experimental | Patients naïve to checkpoint inhibitor (CPI) therapy will receive a combination of weekly HS-110 administered as 5 intradermal 0.1 mL injections at a dose of 1 × 107 viable cells/ 0.5 mL for 18 weeks and bi-weekly nivolumab infusions. After 18 weeks of treatment, patients will continue on monotherapy standard of care nivolumab until confirmed disease progression or unacceptable toxicity, whichever occurs first. After the completion of 18 weeks of combination therapy, patients may receive either nivolumab dosing schedule listed in the current approved package insert (every 2 weeks or every 4 weeks) per Investigator discretion. Receives: Biological: Viagenpumatucel-L; Drug: Nivolumab |
| Arm 6: Viagenpumatucel-L + pembrolizumab | Experimental | HS-110 dosing to be initiated at/before the start of the 3rd maintenance treatment cycle, or within 19 weeks of front-line pembrolizumab monotherapy. Patients will receive a combination of weekly HS-110 administered as 5 intradermal 0.1 mL injections at a dose of 1 × 107 viable cells/0.5 mL for 13 weeks in combination with SOC pembrolizumab every 3 weeks. Following the 13-week priming period, HS-110 injections will be administered for boosting every 3 weeks in combination with SOC pembrolizumab until confirmed disease progression or unacceptable toxicity, whichever occurs first. Receives: Biological: Viagenpumatucel-L; Drug: Pembrolizumab |
| Arm 5: Viagenpumatucel-L + Nivolumab CPI Progressor | Experimental | Patients with prior checkpoint inhibitor (CPI) therapy will receive a combination of weekly HS-110 administered as 5 intradermal 0.1 mL injections at a dose of 1 × 107 viable cells/ 0.5 mL for 18 weeks and bi-weekly nivolumab infusions. After 18 weeks of treatment, patients will continue on monotherapy standard of care nivolumab until confirmed disease progression or unacceptable toxicity, whichever occurs first. After the completion of 18 weeks of combination therapy, patients may receive either nivolumab dosing schedule listed in the current approved package insert (every 2 weeks or every 4 weeks) per Investigator discretion. Receives: Biological: Viagenpumatucel-L; Drug: Nivolumab |
| Arm 6: Viagenpumatucel-L + pembrolizumab + pemetrexed | Experimental | HS-110 dosing to be initiated at/before the start of the 3rd maintenance treatment cycle, or within 19 weeks of front-line pembrolizumab monotherapy. Patients will receive a combination of weekly HS-110 administered as 5 intradermal 0.1 mL injections at a dose of 1 × 107 viable cells/0.5 mL for 13 weeks in combination with SOC pembrolizumab + pemetrexed every 3 weeks. Following the 13-week priming period, HS-110 injections will be administered for boosting every 3 weeks in combination with SOC pembrolizumab + pemetrexed until confirmed disease progression or unacceptable toxicity, whichever occurs first. Receives: Biological: Viagenpumatucel-L; Drug: Pembrolizumab; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Frequency of Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v4.03.
The number and percent of patients with a given TEAE will be summarized overall and by system organ class and preferred term by treatment group. The number and percent of patients with TEAEs will be tabulated by maximum severity.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start15 Apr 2015
- Primary completion3 May 2021
- Study completion4 Nov 2022
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 Non-small Cell Lung CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heat Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Morgensztern, MD, Principal investigator, Washington University School of Medicine in St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439450
- Sponsor's protocol ID
- HS110-102
- Status last verified
- Oct 2022
- First submitted
- 4 May 2015
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study of Viagenpumatucel-L (HS-110) in Combination With Multiple Treatment Regimens in Patients With Non-Small Cell Lung Cancer (The "DURGA" Trial)
- ClinicalTrials.gov ID
- NCT02439450
- Acronym / sponsor ID
- HS110-102
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- lung, cancer, gp96, vaccine, immunotherapy, Heat Biologics, Nivolumab, checkpoint inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Heat BiologicsIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether vaccination with viagenpumatucel-L combined with strategies to modulate the immune response is safe for patients with non-small cell lung adenocarcinoma or squamous cell carcinoma for incurable or metastatic disease.
Detailed description
This study will test whether vaccination with viagenpumatucel-L combined with strategies to modulate the immune response is safe for patients with non-small cell lung adenocarcinoma or squamous cell carcinoma for incurable or metastatic disease. These methods collectively use the body's immune system to target the patient's own tumor. Immunosuppression hinders that response, and may develop in NSCLC patients in a variety of ways, such as activation of checkpoint pathways in the tumor microenvironment. Drugs that disrupt checkpoint molecule signaling like anti-PD-1 monoclonal antibodies nivolumab, may release this brake on the immune system. Tumor expression of PD-L1 plays an important role in patient response to checkpoint inhibitors; in general, clinical response to checkpoint inhibitors requires tumor expression of PD-L1 and presence of Tumor Infiltrating Lymphocytes (TIL). Combining viagenpumatucel-L with anti-PD-1 agents may enhance the vaccine's anti-tumor activity while prolonging or increasing the efficacy of the checkpoint inhibitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 5: Viagenpumatucel-L + Nivolumab CPI Naive | Experimental | Biological: Viagenpumatucel-L, Drug: NivolumabPatients naïve to checkpoint inhibitor (CPI) therapy will receive a combination of weekly HS-110 administered as 5 intradermal 0.1 mL injections at a dose of 1 × 107 viable cells/ 0.5 mL for 18 weeks and bi-weekly nivolumab infusions. After 18 weeks of treatment, patients will continue on monotherapy standard of care nivolumab until confirmed disease progression or unacceptable toxicity, whichever occurs first. After the completion of 18 weeks of combination therapy, patients may receive either nivolumab dosing schedule listed in the current approved package insert (every 2 weeks or every 4 weeks) per Investigator discretion. |
| Arm 6: Viagenpumatucel-L + pembrolizumab | Experimental | Biological: Viagenpumatucel-L, Drug: PembrolizumabHS-110 dosing to be initiated at/before the start of the 3rd maintenance treatment cycle, or within 19 weeks of front-line pembrolizumab monotherapy. Patients will receive a combination of weekly HS-110 administered as 5 intradermal 0.1 mL injections at a dose of 1 × 107 viable cells/0.5 mL for 13 weeks in combination with SOC pembrolizumab every 3 weeks. Following the 13-week priming period, HS-110 injections will be administered for boosting every 3 weeks in combination with SOC pembrolizumab until confirmed disease progression or unacceptable toxicity, whichever occurs first. |
| Arm 5: Viagenpumatucel-L + Nivolumab CPI Progressor | Experimental | Biological: Viagenpumatucel-L, Drug: NivolumabPatients with prior checkpoint inhibitor (CPI) therapy will receive a combination of weekly HS-110 administered as 5 intradermal 0.1 mL injections at a dose of 1 × 107 viable cells/ 0.5 mL for 18 weeks and bi-weekly nivolumab infusions. After 18 weeks of treatment, patients will continue on monotherapy standard of care nivolumab until confirmed disease progression or unacceptable toxicity, whichever occurs first. After the completion of 18 weeks of combination therapy, patients may receive either nivolumab dosing schedule listed in the current approved package insert (every 2 weeks or every 4 weeks) per Investigator discretion. |
| Arm 6: Viagenpumatucel-L + pembrolizumab + pemetrexed | Experimental | Biological: Viagenpumatucel-L, Drug: Pembrolizumab, Drug: PemetrexedHS-110 dosing to be initiated at/before the start of the 3rd maintenance treatment cycle, or within 19 weeks of front-line pembrolizumab monotherapy. Patients will receive a combination of weekly HS-110 administered as 5 intradermal 0.1 mL injections at a dose of 1 × 107 viable cells/0.5 mL for 13 weeks in combination with SOC pembrolizumab + pemetrexed every 3 weeks. Following the 13-week priming period, HS-110 injections will be administered for boosting every 3 weeks in combination with SOC pembrolizumab + pemetrexed until confirmed disease progression or unacceptable toxicity, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Non-small cell lung adenocarcinoma or squamous cell carcimona
- At least one site of measurable disease by RECIST 1.1
- Arm 5: Received at least one prior line of therapy, but no more than three prior lines of therapy, for incurable (i.e. unresectable) or metastatic NSCLC. Up to one prior line of FDA-approved checkpoint inhibitor therapy is permitted (must have received at least 4 months of treatment) --OR--
- Arm 6: Received front line immunotherapy (with or without chemotherapy) for incurable or metastatic NSCLC and did not progress clinically or radiographically per RECIST 1.1 at the most recent imaging assessment, and will begin maintenance immunotherapy with standard of care pembrolizumab ± pemetrexed.
- Life expectancy ≥18 weeks
Key exclusion criteria (12 listed)
- Arm 5: Received systemic anticancer therapy within 21 days prior to first dose of study drug
- Human immunodeficiency virus (HIV), hepatitis B or C, or severe/uncontrolled infections or concurrent illness, unrelated to the tumor, requiring active therapy
- Any condition requiring concurrent systemic immunosuppressive therapy
- Known immunodeficiency disorders, either primary or acquired
- Known leptomeningeal disease
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 |
|---|---|---|
| Viagenpumatucel-LAlso: HS-110Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig | Biological | Arm 5: Viagenpumatucel-L + Nivolumab CPI Naive, Arm 5: Viagenpumatucel-L + Nivolumab CPI Progressor, Arm 6: Viagenpumatucel-L + pembrolizumab, Arm 6: Viagenpumatucel-L + pembrolizumab + pemetrexed |
| NivolumabAlso: OpdivoNivolumab 240mg IV q2weeks for 18 weeks or until disease progression or unacceptable toxicity. After the completion of 18 weeks of combination therapy, patients may receive either nivolumab dosing schedule listed in the current approved package insert (every 2 weeks or every 4 weeks) per Investigator discretion. | Drug | Arm 5: Viagenpumatucel-L + Nivolumab CPI Naive, Arm 5: Viagenpumatucel-L + Nivolumab CPI Progressor |
| PembrolizumabAlso: KeytrudaThe recommended dose of KEYTRUDA (pembrolizumab) is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. | Drug | Arm 6: Viagenpumatucel-L + pembrolizumab, Arm 6: Viagenpumatucel-L + pembrolizumab + pemetrexed |
| PemetrexedAlso: AlimtaThe recommended dose of ALIMTA (pemetrexed) when administered with carboplatin and pembrolizumab for the initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 administered as an intravenous infusion over 10 minutes prior to carboplatin on Day 1 of each 21-day cycle for 4 cycles. Pembrolizumab should be administered prior to ALIMTA when given on the same day. | Drug | Arm 6: Viagenpumatucel-L + pembrolizumab + pemetrexed |
Primary outcome
Phase 1b: Frequency of Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v4.03.
Time frame: Up to 3 years
The number and percent of patients with a given TEAE will be summarized overall and by system organ class and preferred term by treatment group. The number and percent of patients with TEAEs will be tabulated by maximum severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel Morgensztern, MD principal investigator
Washington University School of Medicine in St. Louis
16 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 Viagenpumatucel-L, Nivolumab and Pembrolizumab in people with Non-small Cell Lung Cancer, run by Heat Biologics at 16 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 15 inclusion and 12 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 21 Sep 2023). 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?
Phase 1b: Frequency of Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v4.03. (time frame: Up to 3 years). 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 21 Sep 2023.