Solid Tumors Induced by Prior Radiation ExposurePhase 2NCT02864316
Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure
A Phase 2 study testing Nivolumab in people with Solid Tumors Induced by Prior Radiation Exposure, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Nivolumab is effective in the treatment of radiation-induced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors Induced by Prior Radiation Exposure
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Sep 2018
- 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
- Histologically confirmed metastatic or unresectable solid tumor which standard curative or palliative measures do not exist or are no longer effective. The primary site of the metastatic or unresectable tumor must have arisen within a previously irradiated site and be considered a radiation-induced tumor.
- Pre-treatment tumor specimen available. Patients with no available archived specimen must be willing to undergo a pre-treatment tumor biopsy.
- Measurable disease.
- Progressive disease on study entry.
- Received adjuvant or neoadjuvant chemotherapy and developed recurrent or metastatic disease within 6 months of completing therapy.
- Age >18 years.
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- Eastern Cooperative Oncology Group (ECOG) performance status <2.
- Life expectancy of greater than 3 months.
- Adequate organ and marrow function as defined below:
- White Blood Cell >2,000/per microliter
- Absolute neutrophil count >1,500/per microliter
- Platelets >100,000/per microliter
- Hemoglobin ≥9.0 g/dL
- Total bilirubin ≤1.5 times the institutional upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
- Aspartate Aminotransferase(SGOT)/Alanine Aminotransferase (SGPT) <3 X institutional ULN
- Creatinine ≤1.5 X institutional ULN OR
- Creatinine clearance >40 mL/min for patients with creatinine Levels above institutional normal (calculated using the Cockcroft-Gault formula below)
- Female Creatinine Clearance = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL
- Male Creatinine Clearance = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL
- Women of childbearing potential (WOCBP) and men must agree to use adequate contraception prior to study entry and for the duration of study participation and up to 31 weeks after the last dose of nivolumab.
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of nivolumab.
- Ability to understand and the willingness to sign a written informed consent document.
- Biopsiable disease at the time of enrollment as biopsies after progression are required for participation.
Who cannot join
- Any active, known or suspected autoimmune disease.
- Requiring continuous supplemental oxygen.
- Chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or unresolved toxicity due to agents administered more than 2 weeks earlier.
- Uncontrolled brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.
- Uncontrolled inter-current illness.
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- Pregnant or currently breastfeeding.
- Receiving any other anticancer therapy.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA- 4 antibody therapies, any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating ongoing acute or chronic infection.
- Requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center @ Johns Hopkins
Baltimore, Maryland, 21231
About this study
The purpose of this study is to determine whether Nivolumab is effective in the treatment of radiation-induced solid tumors.
- Being tested
- Nivolumab
- Keywords
- radiation-induced solid tumors, Nivolumab, Phase 2 study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called BMS-936558, MDX-1106
| Study group | Role | What they receive |
|---|---|---|
| Radiation-Induced Metastatic Sarcoma | Experimental | a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Receives: Drug: Nivolumab |
| Radiation-Induced Non-Sarcoma Metastatic Solid Tumors | Experimental | a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Objective Response Rate
Number of participants with response. Response will be assessed at baseline (within 4 weeks prior to starting nivolumab) and then every 8 weeks while on Nivolumab, up to 24 weeks. The best objective response will be assessed at 24 weeks. Response will be defined based on RECIST 1.1 criteria where complete response (CR)= disappearance of all target lesions, partial response (PR) is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
Measured: Up to 24 weeks
Secondary outcomes (5)
Percentage of Patients Progression-free at 24 Weeks From the Time of Enrollment
Disease status at 24 weeks will be compared to disease status at the time of enrollment, and response coded based on RECIST 1.1 criteria.
Measured: 24 weeks
Progression-free Survival
Number of participants alive without progression.
Measured: Up to 22 months
Duration of Response
The duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, accessed up to 3 years.
Measured: Up to 22 months
Number of Participants With Treatment-related Adverse Events
Number of participants with treatment-related adverse events as defined by CTCAE 4.0 criteria.
Measured: up to 100 days post-intervention
Overall Survival
Overall survival was planned to be measured at 5 years post-intervention as the time from enrollment until death. Instead, due to early termination for low accrual, the number of participants alive at the time of study termination is reported.
Measured: Up to 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2018
- Study completionSep 2018
Why it stopped: Poor accrual
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 Solid Tumors Induced by Prior Radiation ExposureStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Patrick Forde, MB, BCH, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864316
- Sponsor's protocol ID
- J1695
- Other IDs
- IRB00105682
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2016
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure
- ClinicalTrials.gov ID
- NCT02864316
- Acronym / sponsor ID
- J1695
- Keywords
- radiation-induced solid tumors, Nivolumab, Phase 2 study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Dec 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Nivolumab is effective in the treatment of radiation-induced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation-Induced Metastatic Sarcoma | Experimental | Drug: Nivolumaba flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. |
| Radiation-Induced Non-Sarcoma Metastatic Solid Tumors | Experimental | Drug: Nivolumaba flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically confirmed metastatic or unresectable solid tumor which standard curative or palliative measures do not exist or are no longer effective. The primary site of the metastatic or unresectable tumor must have arisen within a previously irradiated site and be considered a radiation-induced tumor.
- Pre-treatment tumor specimen available. Patients with no available archived specimen must be willing to undergo a pre-treatment tumor biopsy.
- Measurable disease.
- Progressive disease on study entry.
- Received adjuvant or neoadjuvant chemotherapy and developed recurrent or metastatic disease within 6 months of completing therapy.
Key exclusion criteria (12 listed)
- Any active, known or suspected autoimmune disease.
- Requiring continuous supplemental oxygen.
- Chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or unresolved toxicity due to agents administered more than 2 weeks earlier.
- Uncontrolled brain metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.
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 |
|---|---|---|
| NivolumabAlso: BMS-936558, MDX-1106 | Drug | Radiation-Induced Metastatic Sarcoma, Radiation-Induced Non-Sarcoma Metastatic Solid Tumors |
Primary outcome
Best Objective Response Rate
Time frame: Up to 24 weeks
Number of participants with response. Response will be assessed at baseline (within 4 weeks prior to starting nivolumab) and then every 8 weeks while on Nivolumab, up to 24 weeks. The best objective response will be assessed at 24 weeks. Response will be defined based on RECIST 1.1 criteria where complete response (CR)= disappearance of all target lesions, partial response (PR) is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
5 secondary outcomes
Percentage of Patients Progression-free at 24 Weeks From the Time of Enrollment
Time frame: 24 weeks
Progression-free Survival
Time frame: Up to 22 months
Duration of Response
Time frame: Up to 22 months
Number of Participants With Treatment-related Adverse Events
Time frame: up to 100 days post-intervention
Overall Survival
Time frame: Up to 22 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Patrick Forde, MB, BCH principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 Nivolumab in people with Solid Tumors Induced by Prior Radiation Exposure, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 23 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: stopped early, as of the sponsor's last update on 28 Aug 2019. 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 28 Aug 2019). 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?
Best Objective Response Rate (time frame: Up to 24 weeks). 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 28 Aug 2019.