NeoplasmsPASIPNCT02909348
Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab
An observational study of Neoplasms and Melanoma, run by Royal Free Hospital NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
There is a new form of cancer treatment called immunotherapy which does not attack cancer directly but works on the immune system to make it more effective. This type of treatment may have side effects which are called autoimmune side effects and are caused by the immune system attacking the normal parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2016to Oct 2019
- Phase
- Observational
- 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
Study population: Patients with advanced malignant melanoma of cutaneous or mucosal origin who are BRaf wild type and eligible for first line immunotherapy with pembrolizumab
Who may be able to join
- Be willing and able to provide written informed consent for the trial.
- Be 18 years of age on day of signing informed consent.
- Have a confirmed metastatic melanoma of cutaneous or mucosal origin, and if cutaneous to be confirmed BRaf wild-type.
- Be willing to provide blood samples in line with the study protocol.
- Have a performance status of 0 to 2 on the ECOG Performance Scale.
- Demonstrate adequate organ function.
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- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication.
- Female subjects of childbearing potential must be willing to use an adequate method of contraception.
- Male subjects of childbearing potential must agree to use an adequate method of contraception.
Who cannot join
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- 7. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
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- 8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- 9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- 10. Has known history of, or any evidence of active, non-infectious pneumonitis.
- 11. Has an active infection requiring systemic therapy. 12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- 13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- 14. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- 15. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- 16. Has a known history of Human Immunodeficiency Virus (HIV). 17. Has known active Hepatitis B or Hepatitis C. 18. Has received a live vaccine within 30 days of planned start of study therapy.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Free London NHS Foundation Trust
London, NW3 2QG
The Royal Cornwall Hospital
Treliske, Truro, TR1 3LQ
About this study
Official title: Phenotyping of Blood Samples to Detect Autoimmune Signature Following Immunotherapy With Pembrolizumab
There is a new form of cancer treatment called immunotherapy which does not attack cancer directly but works on the immune system to make it more effective. This type of treatment may have side effects which are called autoimmune side effects and are caused by the immune system attacking the normal parts of the body. At the moment doctors cannot predict which patients may be at more risk of developing such autoimmune side effects and doctors also cannot predict which patients are more likely to benefit. This study will analyse blood samples from patients receiving immunotherapy to see if markers can be identified to help make such predictions.
Read the detailed description
Immunotherapy is a new approach to treating cancers and the major side effects are classed as autoimmune because the immune system is targeting itself. Currently doctors are not able to identify patients at higher risk of developing such autoimmune toxicities and nor are doctors able to identify patients more likely to respond to such treatment. Markers in the immune system have already been identified which are associated with naturally occurring autoimmune diseases. In this study the investigators will examine immune cells from patients with advanced malignant melanoma receiving immunotherapy treatment with Pembrolizumab to see if similar immune system markers can be identified and if such markers may be related to the development of autoimmune side effects or response to treatment. This would enable better selection of patients for treatment with immunotherapy.
- Being tested
- Pembrolizumab
- Keywords
- Neoplasms, Melanoma, Immunotherapy, Biomarkers
- Medical subject headings
- Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
3mg/kg, intravenous and on day1 of each 21 day cycle until progression or unacceptable toxicity develops.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in immune markers in blood following immunotherapy with pembrolizumab
Measured: 5 fixed time points (baseline, pre-cycle 1, 3 & 5 and 6 months) and 2 optional (after adverse event or response/progression)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2019
- Study completionOct 2019
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 NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, University College, London
- Responsible party
- Principal investigator, David Chao, Royal Free Hospital NHS Foundation Trust
- Investigators
- David Chao, FRCP DPhil, Principal investigator, Royal Free London NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909348
- Sponsor's protocol ID
- 9797
- Acronym
- PASIP
- Status last verified
- Feb 2023
- First submitted
- 13 Sep 2016
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Edner NM, Ntavli E, Petersone L, Wang CJ, Fabri A, Kogimtzis A, Ovcinnikovs V, Ross EM, Heuts F, Elfaki Y, Houghton LP, Talbot T, Sheri A, Pender A, Chao D, Walker LSK. Stratification of PD-1 blockade response in melanoma using pre- and post-treatment immunophenotyping of peripheral blood. Immunother Adv. 2023 Jan 6;3(1):ltad001. doi: 10.1093/immadv/ltad001. eCollection 2023.
PubMed 36818683
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping of Blood Samples to Detect Autoimmune Signature Following Immunotherapy With Pembrolizumab
- ClinicalTrials.gov ID
- NCT02909348
- Acronym / sponsor ID
- PASIP / 9797
- Keywords
- Neoplasms, Melanoma, Immunotherapy, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, University College, London
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 21 Sep 2016 (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.
There is a new form of cancer treatment called immunotherapy which does not attack cancer directly but works on the immune system to make it more effective. This type of treatment may have side effects which are called autoimmune side effects and are caused by the immune system attacking the normal parts of the body. At the moment doctors cannot predict which patients may be at more risk of developing such autoimmune side effects and doctors also cannot predict which patients are more likely to benefit. This study will analyse blood samples from patients receiving immunotherapy to see if markers can be identified to help make such predictions.
Detailed description
Immunotherapy is a new approach to treating cancers and the major side effects are classed as autoimmune because the immune system is targeting itself. Currently doctors are not able to identify patients at higher risk of developing such autoimmune toxicities and nor are doctors able to identify patients more likely to respond to such treatment. Markers in the immune system have already been identified which are associated with naturally occurring autoimmune diseases. In this study the investigators will examine immune cells from patients with advanced malignant melanoma receiving immunotherapy treatment with Pembrolizumab to see if similar immune system markers can be identified and if such markers may be related to the development of autoimmune side effects or response to treatment. This would enable better selection of patients for treatment with immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced malignant melanoma of cutaneous or mucosal origin who are BRaf wild type and eligible for first line immunotherapy with pembrolizumab
Key inclusion criteria (9 listed)
- Be willing and able to provide written informed consent for the trial.
- Be 18 years of age on day of signing informed consent.
- Have a confirmed metastatic melanoma of cutaneous or mucosal origin, and if cutaneous to be confirmed BRaf wild-type.
- Be willing to provide blood samples in line with the study protocol.
- Have a performance status of 0 to 2 on the ECOG Performance Scale.
Key exclusion criteria (14 listed)
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Has a known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to pembrolizumab or any of its excipients.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
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 |
|---|---|---|
| PembrolizumabAlso: Keytruda3mg/kg, intravenous and on day1 of each 21 day cycle until progression or unacceptable toxicity develops. | Drug | – |
Primary outcome
Change in immune markers in blood following immunotherapy with pembrolizumab
Time frame: 5 fixed time points (baseline, pre-cycle 1, 3 & 5 and 6 months) and 2 optional (after adverse event or response/progression)
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 2 Mar 2023.
- Results publication: PubMed 36818683Edner NM, Ntavli E, Petersone L, Wang CJ, Fabri A, Kogimtzis A, Ovcinnikovs V, Ross EM, Heuts F, Elfaki Y, Houghton LP, Talbot T, Sheri A, Pender A, Chao D, Walker LSK. Stratification of PD-1 blockade response in melanoma using pre- and post-treatment immunophenotyping of peripheral blood. Immunother Adv. 2023 Jan 6;3(1):ltad001. doi: 10.1093/immadv/ltad001. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
David Chao, FRCP DPhil principal investigator
Royal Free London NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Melanoma, run by Royal Free Hospital NHS Foundation Trust at 2 sites in United Kingdom.
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 9 inclusion and 14 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 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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.
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?
Change in immune markers in blood following immunotherapy with pembrolizumab (time frame: 5 fixed time points (baseline, pre-cycle 1, 3 & 5 and 6 months) and 2 optional (after adverse event or response/progression)). 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 NCT02909348, 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 2 Mar 2023.