Metastatic MelanomaPhase 2CTLA4 NY-ESO-1NCT01216696
Ipilimumab in Patients With Advanced Melanoma and Spontaneous Preexisting Immune Response to NY-ESO-1
A Phase 2 study testing ipilimumab in people with Metastatic Melanoma, run by National Center for Tumor Diseases, Heidelberg at 1 site in Germany.
Trial summary
This is an Open-label, single-arm, phase II study of ipilimumab in patients with spontaneous preexisting immune response to NY-ESO-1. Preclinical data suggest, that CTLA-4 blockade enhances polyfunctional T cell responses in patients with melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Aug 2016
- 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
- Histologic diagnosis of malignant melanoma; unresectable Stage III melanoma or Stage IV melanoma; Measurable/evaluable disease (as per mWHO criteria), within 28 days before first dose of study drug;
- Preexisting spontaneous immune response to NY-ESO-1, defined by positive results in ELISA above a prespecified cut-off value.
- Previously treated or untreated metastatic melanoma. The previous treatment must have been finished at least 28 days before the first ipilimumab administration. Patients must have recovered from any acute toxicity associated with prior therapy
- Life expectancy of ≥ 16 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Men and women, ages 18 and above.
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- Ability of subject to understand character and individual consequences of the clinical trial
- Required values for initial laboratory tests:
- WBC ≥ 2000/μL
- ANC ≥ 1000/μL
- Platelets ≥ 100 x 103/μL
- Hemoglobin ≥ 9 g/dL (may be transfused)
- Creatinine ≤ 2 x ULN
- AST/ALT ≤ 2.5 x ULN for subjects without liver metastasis≤ 5 x ULN for subjects with liver metastasis
- Bilirubin ≤ 2.0 x ULN
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study
Who cannot join
- Brain Metastasis, unless previously treated, off steroids for at least 4 weeks and considered to be stable (eg, no progression of the treated lesion);
- Primary ocular or mucosal melanoma
- Prior malignancy active within the previous 5 years except for locally curable cancers that have been adequately treated, such as basal or squamous cell skin cancer.
- Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are subjects with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome) are excluded from this study
- Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
- Previous participation with a NY-ESO 1 derived vaccination study.
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- Inadequate hematologic function defined by an absolute neutrophil count (ANC) < 1,000/mm3, a platelet count < 100,000/mm3, or a hemoglobin level < 9 g/dL;
- Inadequate hepatic function defined by a total bilirubin level > 2.0 x ULN except subjects with Gilbert's Syndrome, who must have a total bilirubin < 3.0 ULN. AST and ALT levels ≥ 2.5 times the ULN, or ≥ 5 times the ULN if liver metastases are present;
- Inadequate renal function defined by a serum creatinine level ≥ 2.0 times the ULN, or inadequate creatinine clearance defined as less than 50 mL/min;
- Positive tests for HIV, Hepatitis B, and Hepatitis C. If positive results are not indicative of true active or chronic infection, the patient can enter the study after discussion and agreement with the investigator and the Medical Monitor.
- Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses).
- Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 4 weeks prior to or after any dose of ipilimumab);
- Prior treatment with a CD137 agonist, ipilimumab or other CTLA-4 inhibitor.
- Prisoners or subjects who are involuntarily incarcerated
- Participation in other clinical trials or observation period of competing trials, respectively during the last 30 days before the first application of the investigational agent .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Ipilimumab in Patients With Advanced Melanoma and Spontaneous Preexisting Immune Response to NY-ESO-1
This is an Open-label, single-arm, phase II study of ipilimumab in patients with spontaneous preexisting immune response to NY-ESO-1.
Preclinical data suggest, that CTLA-4 blockade enhances polyfunctional T cell responses in patients with melanoma. Thus patients with immunological response to NY-ESO-1 might benefit from an anti CTLA-4 treatment.
Eligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction period, followed by a radiological assessment in week 12. Patients with clinical benefit (partial response, complete response or stable disease according to the immune-related response criteria) will continue with an ipilimumab administration every 3 months starting at week 24 up to week 48 until the end of the study or until disease progression,toxicities requiring discontinuation
- Conditions
- Metastatic Melanoma
- Being tested
- ipilimumab
- Keywords
- ipilimumab, melanoma, NY-ESO-1
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ipilimumabDrug
Eligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction period, followed by a radiological assessment in week 12. Patients with clinical benefit will continue with an ipilimumab administration every 3 months starting at week 24 up to week 48 until the end of the study or until disease progression, toxicities requiring discontinuation , withdrawal of consent,pregnancy, death or lost to follow up whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention Details:
Drug: ipilimumab
Eligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction period, followed by a radiological assessment in week 12. Patients with clinical benefit will continue with an ipilimumab administration every 3 months starting at week 24 up to week 48 until the end of the study or until disease progression, toxicities requiring discontinuation , withdrawal of consent,pregnancy, death or lost to follow up whichever occurs first. Receives: Drug: ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate according to immune-related response criteria
To determine the efficacy of ipilimumab in patients with stage III and stage IV malignant melanoma and spontaneous preexisting immune response to NY-ESO-1.
Measured: 1 year
Secondary outcomes (3)
Progression-free survival according to the immune-related response criteria
To document progression-free survival (PFS) in patients with evaluable or measurable disease after receiving ipilimumab according to the immune-related response criteria (irRC),
Measured: 1 year
Overall Survival at 12 months
To document overall-survival (OS) rate at 12 months after the first study treatment in patients receiving ipilimumab.
Measured: 1 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To assess the safety profile of ipilimumab in patients with malignant melanoma stage III and IV and spontaneous preexisting immune response to NY-ESO-1.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Tumor Diseases, Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg
- Responsible party
- Sponsor
- Investigators
- Dirk Jäger, MD, Principal investigator, NCT Heidelberg, Dep. of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216696
- Sponsor's protocol ID
- NCT-2009-11-02-53
- Acronym
- CTLA4 NY-ESO-1
- Status last verified
- Aug 2016
- First submitted
- 27 Sep 2010
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haag GM, Zoernig I, Hassel JC, Halama N, Dick J, Lang N, Podola L, Funk J, Ziegelmeier C, Juenger S, Bucur M, Umansky L, Falk CS, Freitag A, Karapanagiotou-Schenkel I, Beckhove P, Enk A, Jaeger D. Phase II trial of ipilimumab in melanoma patients with preexisting humoural immune response to NY-ESO-1. Eur J Cancer. 2018 Feb;90:122-129. doi: 10.1016/j.ejca.2017.12.001. Epub 2018 Jan 5.
PubMed 29306769
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Ipilimumab in Patients With Advanced Melanoma and Spontaneous Preexisting Immune Response to NY-ESO-1
- ClinicalTrials.gov ID
- NCT01216696
- Acronym / sponsor ID
- CTLA4 NY-ESO-1 / NCT-2009-11-02-53
- Conditions
- Metastatic Melanoma
- Keywords
- ipilimumab, melanoma, NY-ESO-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Center for Tumor Diseases, HeidelbergUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg
- Study start
- Nov 2010
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an Open-label, single-arm, phase II study of ipilimumab in patients with spontaneous preexisting immune response to NY-ESO-1.
Preclinical data suggest, that CTLA-4 blockade enhances polyfunctional T cell responses in patients with melanoma. Thus patients with immunological response to NY-ESO-1 might benefit from an anti CTLA-4 treatment.
Eligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction period, followed by a radiological assessment in week 12. Patients with clinical benefit (partial response, complete response or stable disease according to the immune-related response criteria) will continue with an ipilimumab administration every 3 months starting at week 24 up to week 48 until the end of the study or until disease progression,toxicities requiring discontinuation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: ipilimumabIntervention Details: Drug: ipilimumab Eligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction period, followed by a radiological assessment in week 12. Patients with clinical benefit will continue with an ipilimumab administration every 3 months starting at week 24 up to week 48 until the end of the study or until disease progression, toxicities requiring discontinuation , withdrawal of consent,pregnancy, death or lost to follow up 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 (16 listed)
- Histologic diagnosis of malignant melanoma; unresectable Stage III melanoma or Stage IV melanoma; Measurable/evaluable disease (as per mWHO criteria), within 28 days before first dose of study drug;
- Preexisting spontaneous immune response to NY-ESO-1, defined by positive results in ELISA above a prespecified cut-off value.
- Previously treated or untreated metastatic melanoma. The previous treatment must have been finished at least 28 days before the first ipilimumab administration. Patients must have recovered from any acute toxicity associated with prior therapy
- Life expectancy of ≥ 16 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Key exclusion criteria (15 listed)
- Brain Metastasis, unless previously treated, off steroids for at least 4 weeks and considered to be stable (eg, no progression of the treated lesion);
- Primary ocular or mucosal melanoma
- Prior malignancy active within the previous 5 years except for locally curable cancers that have been adequately treated, such as basal or squamous cell skin cancer.
- Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are subjects with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome) are excluded from this study
- Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.
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 |
|---|---|---|
| ipilimumabEligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction period, followed by a radiological assessment in week 12. Patients with clinical benefit will continue with an ipilimumab administration every 3 months starting at week 24 up to week 48 until the end of the study or until disease progression, toxicities requiring discontinuation , withdrawal of consent,pregnancy, death or lost to follow up whichever occurs first. | Drug | Intervention |
Primary outcome
Disease Control Rate according to immune-related response criteria
Time frame: 1 year
To determine the efficacy of ipilimumab in patients with stage III and stage IV malignant melanoma and spontaneous preexisting immune response to NY-ESO-1.
3 secondary outcomes
Progression-free survival according to the immune-related response criteria
Time frame: 1 year
Overall Survival at 12 months
Time frame: 1 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Derived from this study: PubMed 29306769Haag GM, Zoernig I, Hassel JC, Halama N, Dick J, Lang N, Podola L, Funk J, Ziegelmeier C, Juenger S, Bucur M, Umansky L, Falk CS, Freitag A, Karapanagiotou-Schenkel I, Beckhove P, Enk A, Jaeger D. Phase II trial of ipilimumab in melanoma patients with preexisting humoural immune response to NY-ESO-1. Eur J Cancer. 2018 Feb;90:122-129. doi: 10.1016/j.ejca.2017.12.001. Epub 2018 Jan 5.
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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.
Dirk Jäger, MD principal investigator
NCT Heidelberg, Dep. of Medical Oncology
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 ipilimumab in people with Metastatic Melanoma, run by National Center for Tumor Diseases, Heidelberg at 1 site in Germany.
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 16 inclusion and 15 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 12 Aug 2016. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate according to immune-related response criteria (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01216696, which also lists 1 linked publication.
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 12 Aug 2016.