Lung Squamous Cell Carcinoma Stage IVPhase 2ENSIGNNCT02831933
Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma
A Phase 2 study testing ADV/HSV-tk, Valacyclovir and SBRT in people with Lung Squamous Cell Carcinoma Stage IV and Nonsquamous Nonsmall Cell Neoplasm of Lung, run by Eric Bernicker, MD at 1 site in United States.
Trial summary
This is a Phase II trial to determine the efficacy and safety of in situ gene therapy and stereotactic body radiation therapy (SBRT) used as a window of opportunity treatment before nivolumab in patients with metastatic squamous or non-squamous non-small cell lung carcinoma (NSCLC) and metastatic uveal melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Squamous Cell Carcinoma Stage IV, Nonsquamous Nonsmall Cell Neoplasm of Lung, Metastatic Uveal Melanoma
- What is being tested?
- ADV/HSV-tk, Valacyclovir and SBRT
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 5 Nov 2020
- Phase
- Phase 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
- Male or female ≥18 years of age.
- Histologically or cytologically confirmed stage IV, metastatic squamous or non-squamous NSCLC that has progressed after a platinum-based chemotherapy and after a single-agent immunotherapy OR histologically or cytologically confirmed metastatic uveal melanoma that is immunotherapy naive
- Evaluable or measurable disease as per RECIST 1:1, a target lesion of suitable diameter (at least 5 mm) for SBRT, and a non-target lesion of at least 1 cm in diameter for abscopal effect evaluation.
- ≥ 4 weeks since any major surgery.
- A 2-week washout period post any prior systemic anticancer therapy, RT, and/or investigational therapy is required prior to trial entry. Subject should be adequately recovered from the acute toxicities of any prior therapy.
- Life expectancy greater than or equal to 6 months.
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- Eastern Cooperative Oncology Group performance status of 0-1.
- Adequate bone marrow function:
- Absolute neutrophil count ≥ 1.5 x 10^9/L (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
- Platelets ≥ 100 x 10^9/L (without transfusion within 2 weeks of laboratory test used to determine eligibility)
- Hemoglobin ≥ 8 g/dL (without blood transfusion)
- White blood cell count > 2,500/uL and < 15,000/uL
- Lymphocyte count ≥ 500/uL
- Adequate liver function (NSLC Cohort):
- Serum bilirubin less than or equal to 1.0 X upper limit of normal (ULN; patients with known Gilbert's disease who have serum bilirubin level less than or equal to 3 X ULN may be enrolled)
- Serum transaminases (aspartate transaminase [AST] or alanine transaminase [ALT]) activity less than or equal to 2.5 X ULN with normal alkaline phosphatase (patients with liver metastases less than or equal to 5 x ULN) OR AST and ALT less than or equal to 1.5 X ULN with an alkaline phosphatase greater than 2.5 X ULN
- Adequate liver function (uveal melanoma cohort):
- Serum bilirubin less than 1.5 ULN (patients with known Gilbert's disease who have serum bilirubin level 3 ULN may be enrolled)
- Serum transaminases (AST or ALT) activity less than or equal to 4 ULN with normal alkaline phosphatase (patients with liver metastases less than or equal to 5 x ULN) OR AST and ALT less than or equal to 1.5 ULN with an alkaline phosphatase greater than or equal to 2.5 ULN
- International normalized ratio and activated partial thromboplastin time (aPTT) less than or equal to 1.5 X ULN (unless patient is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants)
- Adequate renal function: serum creatinine less than 2 X ULN.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment. Women must not be lactating.
- WOCBP and men must practice an effective method of birth control
- Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks of the study by the investigator (or his/her designee) with the aid of written information.
- Willing to provide biopsies as required by the study.
Who cannot join
- Prior treatment with gene therapy.
- Any immunotherapy within 2 weeks of study treatment start (NSCLC cohort only).
- Prior treatment with immunotherapy (uveal melanoma cohort only)
- Patients with EGFR or ALK genomic tumor aberrations that have not received any FDA-approved therapy for these aberrations (NSCLC cohort only).
- Oxygen-dependent chronic obstructive pulmonary disease (NSCLC cohort only).
- Patients requiring oral prednisone for emphysema management (NSCLC cohort only).
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- History of liver disease, such as cirrhosis or active/chronic hepatitis B or C.
- History of or current alcohol misuse/abuse within the past 12 months.
- Known gallbladder or bile duct disease (i.e., infection or cholecystitis) or acute or chronic pancreatitis.
- Major surgery within 4 weeks prior to study enrollment.
- Uncontrolled brain or leptomeningeal metastases or brain or leptomeningeal metastases requiring continued glucocorticoid treatment. Patients who have been treated at least 4 weeks prior to enrollment and have a CT or magnetic resonance imaging scan of the brain showing no evidence of disease progression within 4 weeks of enrollment are eligible.
- Congestive heart failure: New York Heart Association class III or IV heart failure or unstable angina.
- History of syncope or family history of idiopathic sudden death.
- Sustained or clinically significant cardiac arrhythmias including sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block (Mobitz II or higher atrioventricular nodal block), prolonged heart rate-corrected QT interval (longer than 470 milliseconds), or history of acute myocardial infarction. (The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle)
- Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes or Parkinson's disease), human immunodeficiency virus (HIV), cirrhosis, uncontrolled hypothyroidism, or cardiac failure.
- Presence of active or suspected acute or chronic uncontrolled infection or history of immunocompromise, including a positive HIV test result.
- Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation in the study such as severely impaired lung function, any active (acute or chronic) or uncontrolled infection/disorders, and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the study therapy.
- Known or suspected allergy or hypersensitivity to any component of nivolumab or its analogues or any component of the proposed regimen (gene vector/Valacyclovir).
- Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications (Valacyclovir).
- Any active malignancy except for non-melanoma skin cancer or in situ cervical cancer or treated cancer from which the patient has been continuously disease free for more than 5 years.
- Pregnant or breastfeeding women or women/men able to conceive and unwilling to practice an effective method of birth control.
- Unwilling or unable to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ENSIGN: Phase II Window of Opportunity Trial of Stereotactic Body Radiation Therapy and In Situ Gene Therapy Followed by Nivolumab in Metastatic Squamous or Non-Squamous Non-Small Cell Lung Carcinoma and Metastatic Uveal Melanoma
This is a Phase II trial to determine the efficacy and safety of in situ gene therapy and stereotactic body radiation therapy (SBRT) used as a window of opportunity treatment before nivolumab in patients with metastatic squamous or non-squamous non-small cell lung carcinoma (NSCLC) and metastatic uveal melanoma. In situ gene therapy will consist of adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus Valacyclovir therapy.
Read the detailed description
This is a Phase II trial to determine the efficacy and safety of in situ gene therapy and stereotactic body radiation therapy (SBRT) used as a window of opportunity treatment before nivolumab in patients with metastatic squamous or non-squamous non-small cell lung carcinoma (NSCLC) and metastatic uveal melanoma. In situ gene therapy will consist of adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus Valacyclovir therapy. Male or female patients aged ≥18 years with histologically or cytologically confirmed metastatic squamous or non-squamous NSCLC whose disease has progressed after a platinum-based chemotherapy and a single-agent immunotherapy OR histologically or cytologically confirmed metastatic uveal melanoma that is immunotherapy naive are eligible to participate in the study. NSCLC patients with EGFR or ALK genomic tumor aberrations are eligible only if they have had disease progression on FDA-approved therapy for these aberrations. ADV/HSV-tk (5 x 1011 viral particles) in a 2-mL total volume will be injected intratumorally on day 0 of the study. Valacyclovir will be orally administered at a dose of 2 g three times daily for 14 days. Valacyclovir treatment will be administered 24 hours after the gene vector injection from day 1 to day 15 of the study. SBRT of 30 gray (Gy; 6 Gy X 5 fractions) will be administered over 2 weeks from day 2 to day 16 of the study. Nivolumab (480 mg) will be administered intravenously over 30 minutes every 4 weeks starting on day 17 of the study and continuing until disease progression, unacceptable toxicity, or up to 12 months in patients without disease progression. The primary endpoint will be the objective response rate (ORR) of ADV/HSV-tk + Valacyclovir therapy in combination with SBRT used as a window of opportunity treatment before nivolumab in patients with metastatic squamous or non-squamous NSCLC. Both RECIST 1.1 and modified immune-related response criteria (irRC; derived from RECIST 1.1) will be used to assess treatment response. Secondary endpoints will include a) clinical benefit rate (CBR); b) duration of response (DoR); c) overall survival (OS) and progression-free survival (PFS) rates; d) safety and toxicity (toxicity will be defined as any treatment-related death or any ≥ grade 3 toxicity excluding alopecia and constitutional symptoms as assessed by the NCI CTCAE v4.03); and e) immune-mediated antitumor activity (assessed by RECIST 1.1 and modified irRC) of ADV/HSV-tk plus Valacyclovir therapy in combination with SBRT used as a window of opportunity treatment before nivolumab.
- Conditions
- Lung Squamous Cell Carcinoma Stage IV, Nonsquamous Nonsmall Cell Neoplasm of Lung, Metastatic Uveal Melanoma
- Keywords
- lung cancer, metastatic, gene therapy, immunotherapy, melanoma, uveal
- Medical subject headings
- Uveal Melanoma, Lung Neoplasms, Neoplasm Metastasis, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADV/HSV-tkBiological
Replication-defective recombinant adenovirus vector
ValacyclovirDrug
Also called valacyclovir hydrochloride
Prodrug of the antiviral drug acyclovir
SBRTRadiation
Low-dose SBRT
nivolumabDrug
Also called Opdivo
Fully human immunoglobulin (Ig) G4 anti-PD-1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | ADV/HSV-tk (5 x 1011 viral particles) in a 2-mL total volume will be injected intratumorally on day 0 of the study.
Valacyclovir will be orally administered at a dose of 2 g three times daily for 14 days. Valacyclovir treatment will be administered 24 hours after the gene vector injection from day 1 to day 15 of the study.
SBRT of 30 gray (Gy; 6 Gy X 5 fractions) will be administered over 2 weeks from day 2 to day 16 of the study.
Nivolumab (480 mg) will be administered intravenously over 30 minutes every 4 weeks starting on day 17 of the study and continuing until disease progression, unacceptable toxicity, or up to 12 months in patients without disease progression. Receives: Biological: ADV/HSV-tk; Drug: Valacyclovir; Radiation: SBRT; Drug: nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Determine the ORR of ADV/HSV-tk plus Valacyclovir therapy in combination with SBRT used as a window of opportunity treatment before nivolumab. Administration of ADV/HSV-tk + Valacyclovir in combination with SBRT before nivolumab represents a novel window of opportunity to enhance nivolumab efficacy by boosting endogenous immune-mediated antitumor activity and neoantigen expression.
The concepts of the irRC are combined with RECIST 1.1 to come up with the modified irRC, which uses unidimensional measurements. For modified irRC, only target and measurable lesions are taken into account. The same assessment method and technique should be used to characterize each identified and reported target lesion(s) at baseline, during the trial, and at EOT. All measurements should be recorded in metric notation.
Measured: 30 days after the last dose of nivolumab, up to 6 months
Secondary outcomes (3)
Overall Survival (OS) Rate
Determine the OS rate. Months from start of treatment till date of death.
Measured: 30 days after the last dose of nivolumab, up to 6 months
Progression Free Survival (PFS) Rate
Determine the Progression Free Survival (PFS) rate.
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, using the smallest sum on study (includes the baseline sum) as the reference. In addition to the relative 20% increase, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)
Overall irPD: ≥ 20% increase in the sum of the longest diameters of target and new measurable lesions increases (compared to nadir), confirmed by a repeat, consecutive observation at least 6 weeks (normally it should be done at 8 weeks) from the date first documented.
Documentation of immune-related PD (based on modified irRC) does not mandate discontinuation of the study treatment even after irPD is confirmed with CT scan 6 weeks after the initial observation of irPD.
Measured: 30 days after the last dose of nivolumab, up to 6 months
Clinical Benefit Rate (CBR)
Estimate the CBR as assessed by RECIST 1.1 and modified immune-related criteria
Measured: 30 days after the last dose of nivolumab, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start15 Feb 2017
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Why it stopped: Lack of funding
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 Lung Squamous Cell Carcinoma Stage IVStudies 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
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Bernicker, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Bernicker, MD, The Methodist Hospital Research Institute
- Investigators
- Eric Bernicker, M.D., Principal investigator, Houston Methodist Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831933
- Sponsor's protocol ID
- Pro00014976
- Acronym
- ENSIGN
- Status last verified
- Aug 2023
- First submitted
- 1 Jul 2016
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and materials on human subjects will be shared with other eligible investigators through appropriate means in accordance with the NIH policy on Sharing Research Data (NIH Guide, February 26, 2003). Data will be also shared with the funding agency and regulatory agencies as required. Data will be shared with other investigators within the limits of HIPAA and other patient confidentiality requirements. This will generally require removal of all patient identifiers for all source documents and the use of arbitrarily assigned one-way identifiers. In some cases, requestors will be asked to sign a formal data sharing agreement that will provide for a commitment to use data only for research purposes and not to identify individuals, keep the data secure, and destroy or return data after analyses are complete. Prior approval will be obtained from collaborating investigators, research sponsors, and/or other stake-holders before sharing if proprietary information or products are involved.
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
- ENSIGN: Phase II Window of Opportunity Trial of Stereotactic Body Radiation Therapy and In Situ Gene Therapy Followed by Nivolumab in Metastatic Squamous or Non-Squamous Non-Small Cell Lung Carcinoma and Metastatic Uveal Melanoma
- ClinicalTrials.gov ID
- NCT02831933
- Acronym / sponsor ID
- ENSIGN / Pro00014976
- Conditions
- Lung Squamous Cell Carcinoma Stage IV, Nonsquamous Nonsmall Cell Neoplasm of Lung, Metastatic Uveal Melanoma
- Keywords
- lung cancer, metastatic, gene therapy, immunotherapy, melanoma, uveal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Eric Bernicker, MDUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 13 Jul 2016 (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 is a Phase II trial to determine the efficacy and safety of in situ gene therapy and stereotactic body radiation therapy (SBRT) used as a window of opportunity treatment before nivolumab in patients with metastatic squamous or non-squamous non-small cell lung carcinoma (NSCLC) and metastatic uveal melanoma. In situ gene therapy will consist of adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus Valacyclovir therapy.
Detailed description
This is a Phase II trial to determine the efficacy and safety of in situ gene therapy and stereotactic body radiation therapy (SBRT) used as a window of opportunity treatment before nivolumab in patients with metastatic squamous or non-squamous non-small cell lung carcinoma (NSCLC) and metastatic uveal melanoma. In situ gene therapy will consist of adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus Valacyclovir therapy. Male or female patients aged ≥18 years with histologically or cytologically confirmed metastatic squamous or non-squamous NSCLC whose disease has progressed after a platinum-based chemotherapy and a single-agent immunotherapy OR histologically or cytologically confirmed metastatic uveal melanoma that is immunotherapy naive are eligible to participate in the study. NSCLC patients with EGFR or ALK genomic tumor aberrations are eligible only if they have had disease progression on FDA-approved therapy for these aberrations. ADV/HSV-tk (5 x 1011 viral particles) in a 2-mL total volume will be injected intratumorally on day 0 of the study. Valacyclovir will be orally administered at a dose of 2 g three times daily for 14 days. Valacyclovir treatment will be administered 24 hours after the gene vector injection from day 1 to day 15 of the study. SBRT of 30 gray (Gy; 6 Gy X 5 fractions) will be administered over 2 weeks from day 2 to day 16 of the study. Nivolumab (480 mg) will be administered intravenously over 30 minutes every 4 weeks starting on day 17 of the study and continuing until disease progression, unacceptable toxicity, or up to 12 months in patients without disease progression. The primary endpoint will be the objective response rate (ORR) of ADV/HSV-tk + Valacyclovir therapy in combination with SBRT used as a window of opportunity treatment before nivolumab in patients with metastatic squamous or non-squamous NSCLC. Both RECIST 1.1 and modified immune-related response criteria (irRC; derived from RECIST 1.1) will be used to assess treatment response. Secondary endpoints will include a) clinical benefit rate (CBR); b) duration of response (DoR); c) overall survival (OS) and progression-free survival (PFS) rates; d) safety and toxicity (toxicity will be defined as any treatment-related death or any ≥ grade 3 toxicity excluding alopecia and constitutional symptoms as assessed by the NCI CTCAE v4.03); and e) immune-mediated antitumor activity (assessed by RECIST 1.1 and modified irRC) of ADV/HSV-tk plus Valacyclovir therapy in combination with SBRT used as a window of opportunity treatment before nivolumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: ADV/HSV-tk, Drug: Valacyclovir, Radiation: SBRT, Drug: nivolumabADV/HSV-tk (5 x 1011 viral particles) in a 2-mL total volume will be injected intratumorally on day 0 of the study. Valacyclovir will be orally administered at a dose of 2 g three times daily for 14 days. Valacyclovir treatment will be administered 24 hours after the gene vector injection from day 1 to day 15 of the study. SBRT of 30 gray (Gy; 6 Gy X 5 fractions) will be administered over 2 weeks from day 2 to day 16 of the study. Nivolumab (480 mg) will be administered intravenously over 30 minutes every 4 weeks starting on day 17 of the study and continuing until disease progression, unacceptable toxicity, or up to 12 months in patients without disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Male or female ≥18 years of age.
- Histologically or cytologically confirmed stage IV, metastatic squamous or non-squamous NSCLC that has progressed after a platinum-based chemotherapy and after a single-agent immunotherapy OR histologically or cytologically confirmed metastatic uveal melanoma that is immunotherapy naive
- Evaluable or measurable disease as per RECIST 1:1, a target lesion of suitable diameter (at least 5 mm) for SBRT, and a non-target lesion of at least 1 cm in diameter for abscopal effect evaluation.
- ≥ 4 weeks since any major surgery.
- A 2-week washout period post any prior systemic anticancer therapy, RT, and/or investigational therapy is required prior to trial entry. Subject should be adequately recovered from the acute toxicities of any prior therapy.
Key exclusion criteria (22 listed)
- Prior treatment with gene therapy.
- Any immunotherapy within 2 weeks of study treatment start (NSCLC cohort only).
- Prior treatment with immunotherapy (uveal melanoma cohort only)
- Patients with EGFR or ALK genomic tumor aberrations that have not received any FDA-approved therapy for these aberrations (NSCLC cohort only).
- Oxygen-dependent chronic obstructive pulmonary disease (NSCLC cohort only).
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 |
|---|---|---|
| ADV/HSV-tkReplication-defective recombinant adenovirus vector | Biological | Experimental |
| ValacyclovirAlso: valacyclovir hydrochlorideProdrug of the antiviral drug acyclovir | Drug | Experimental |
| SBRTLow-dose SBRT | Radiation | Experimental |
| nivolumabAlso: OpdivoFully human immunoglobulin (Ig) G4 anti-PD-1 monoclonal antibody | Drug | Experimental |
Primary outcome
Overall Response Rate (ORR)
Time frame: 30 days after the last dose of nivolumab, up to 6 months
Determine the ORR of ADV/HSV-tk plus Valacyclovir therapy in combination with SBRT used as a window of opportunity treatment before nivolumab. Administration of ADV/HSV-tk + Valacyclovir in combination with SBRT before nivolumab represents a novel window of opportunity to enhance nivolumab efficacy by boosting endogenous immune-mediated antitumor activity and neoantigen expression. The concepts of the irRC are combined with RECIST 1.1 to come up with the modified irRC, which uses unidimensional measurements. For modified irRC, only target and measurable lesions are taken into account. The same assessment method and technique should be used to characterize each identified and reported target lesion(s) at baseline, during the trial, and at EOT. All measurements should be recorded in metric notation.
3 secondary outcomes
Overall Survival (OS) Rate
Time frame: 30 days after the last dose of nivolumab, up to 6 months
Progression Free Survival (PFS) Rate
Time frame: 30 days after the last dose of nivolumab, up to 6 months
Clinical Benefit Rate (CBR)
Time frame: 30 days after the last dose of nivolumab, up to 6 months
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.
- Individual participant dataSharing planned: Yes. Data and materials on human subjects will be shared with other eligible investigators through appropriate means in accordance with the NIH policy on Sharing Research Data (NIH Guide, February 26, 2003). Data will be also shared with the funding agency and regulatory agencies as required. Data will be shared with other investigators within the limits of HIPAA and other patient confidentiality requirements. This will generally require removal of all patient identifiers for all source documents and the use of arbitrarily assigned one-way identifiers. In some cases, requestors will be asked to sign a formal data sharing agreement that will provide for a commitment to use data only for research purposes and not to identify individuals, keep the data secure, and destroy or return data after analyses are complete. Prior approval will be obtained from collaborating investigators, research sponsors, and/or other stake-holders before sharing if proprietary information or products are involved.
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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.
Eric Bernicker, M.D. principal investigator
Houston Methodist Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADV/HSV-tk, Valacyclovir and SBRT in people with Lung Squamous Cell Carcinoma Stage IV and Nonsquamous Nonsmall Cell Neoplasm of Lung, run by Eric Bernicker, MD 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 25 inclusion and 22 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 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 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 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?
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?
Overall Response Rate (ORR) (time frame: 30 days after the last dose of nivolumab, up to 6 months). 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.