MalignantPhase 2SKOPOSNCT01569919
A Phase II Trial to Assess TroVax® Plus Chemotherapy in Patients With Malignant Pleural Mesothelioma
A Phase 2 study testing TroVax®, Pemetrexed and Cisplatin in people with Malignant and Pleural, run by Wales Cancer Trials Unit at 1 site in United Kingdom.
Trial summary
This study is for patients with malignant mesothelioma of the lung lining (called pleura) who are planning to have pemetrexed-cisplatin chemotherapy. We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin chemotherapy is both safe and potentially beneficial in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant, Pleural, Mesothelioma
- What is being tested?
- TroVax®, Pemetrexed and Cisplatin
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to Dec 2014
- 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
- Signed and dated written informed consent obtained from the patient in accordance with the local regulations
- Locally advanced or metastatic, histologically or cytologically proven MPM
- Aged 18 years or over
- WHO performance status 0-1 (Appendix I)
- Life expectancy > 6months
- Haemoglobin ≥ 12 g/dl, total white cell count ≥ 3 x 10^9/L, neutrophil count > 1.5 x 10^9/L, lymphocyte count ≥1 x 10^9/L, monocyte count <0.8 x 10^9/L platelet count >100 x 10^9/L and <400 x 10^9/L. Blood transfusion is allowed.
Show all 11Show fewer
- Adequate renal function: Creatinine ≥ 50 mL/min as measured by EDTA or 60mL/min as measured by the Cockcroft-Gault formula
- Adequate liver function: ALT, AST and bilirubin < 2 times the upper limit of normal
- At least four weeks from any previous therapy including surgery, or radiotherapy
- Able to comply with the protocol
- Women must be either post-menopausal, or rendered surgically sterile or, if of child-bearing potential, must have a negative pregnancy test prior to trial entry. Two reliable forms of contraception (oral contraception and a barrier method) must be used by all participants while they are being treated with the TroVax® vaccine. Females must continue to use this level of contraception for 3 months following the last trial treatment, and male patients must continue for 1 month.
Who cannot join
- Serious infections within the 28 days prior to entry to the trial.
- Prior TroVax® treatment
- Previous chemotherapy for MPM
- Major surgery or radiation therapy completed ≤ 4 weeks prior to enrolment
- Prior radiopharmaceuticals (strontium, samarium) less than 8 weeks prior to enrolment
- Participation in any other clinical trial of a licensed or unlicensed drug within the previous 30 days
Show all 17Show fewer
- History of prior malignant disease unless patient has been disease-free for at least 3 years or the tumour was a non-melanoma skin cancer or early cervical cancer
- Autoimmune disease including systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependent diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease
- Clinical significant cardiac failure or a measured ejection fraction of <40%
- Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient inappropriate for entry into this study.
- Chronic corticosteroid use unless prescribed as replacement therapy in the case of adrenal insufficiency, or other immunosuppressive agents. Dexamethasone is allowed as part of trial treatment.
- Cerebral metastases
- History of allergic response to previous vaccine vaccinations
- Known allergy to egg proteins
- Known to test positive for HIV or hepatitis B or C
- Pregnancy or lactation
- Prior history of organ transplantation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Velindre Cancer Centre
Cardiff, South Wales, CF14 2TL
Mick Button
About this study
Official title: A Phase II Trial to Assess the Safety, Immunological Activity of TroVax® Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma
This study is for patients with malignant mesothelioma of the lung lining (called pleura) who are planning to have pemetrexed-cisplatin chemotherapy.
We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This vaccine has been used in combination with chemotherapy in other types of cancer and has been shown to be safe. Cancer vaccines work by stimulating the person's immune system to fight the disease, in a similar way to the immune system fighting infection. In laboratory experiments, the vaccine has been shown to stimulate an immune response to a particular protein widely found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4 protein.
Read more
Pemetrexed-cisplatin chemotherapy is currently seen as the best treatment for patients with mesothelioma, and this is why we plan to combine it with the vaccine. It is hoped that the combination of the TroVax® vaccine and chemotherapy is more beneficial than chemotherapy alone.
Pemetrexed-cisplatin will be given into a vein in the arm (intravenously) every 3 weeks. The TroVax® vaccine will be given as an injection into the shoulder muscle (intramuscularly) 3 weeks before chemotherapy starts, one week before chemotherapy starts, then every 3 weeks. Each participant will receive 4 chemotherapy and 9 vaccine treatments if they complete the planned trial schedule. We aim to recruit 26 patients into the trial over a two year period. If this study shows that pemetrexed-cisplatin chemotherapy plus the TroVax® vaccine is safe and beneficial in terms of stimulating the immune system, the combination will be tested further in larger clinical trials.
- Conditions
- Malignant, Pleural, Mesothelioma
- Being tested
- TroVax®, Pemetrexed, Cisplatin, Vitamin B12, Folic Acid
- Keywords
- Phase II, Single arm, Vaccine
- Medical subject headings
- Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TroVax®Biological
Dose of 1 x 10^9 TCID 50/ml, in 1ml, given on day 1 of weeks 1, 3, 6, 9, 12, 15, 18, 21, 24.
PemetrexedDrug
500 mg/m^2 over 10 mins, given on day 3 of weeks 4, 7, 10, 13.
CisplatinDrug
75mg/m^2 over 1 hour, given on day 3 of weeks 4, 7, 10, 13
Vitamin B12Dietary supplement
1000μg intramuscular, Day 2 of weeks 3 and 12
Folic AcidDietary supplement
400μg oral daily from Day 2 of week 3 to Day 2 of week 16
DexamethasoneDrug
4mg BD, Days 2-6 of weeks 4, 7, 10, 13
| Study group | Role | What they receive |
|---|---|---|
| TroVax® | Experimental | In this single-arm study, all participants will receive 9 injections of the TroVax® vaccine, plus standard cisplatin and pemetrexed chemotherapy. Receives: Biological: TroVax®; Drug: Pemetrexed; Drug: Cisplatin; Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response to 5T4 and MVA antigens as measured by intracellular cytokine staining (ICCS)
To evaluate whether TroVax® is active in the treatment of MPM. This will be assessed by measuring the cellular or humoral anti-5T4 immune responses following treatment with TroVax® given in combination with Pem/Cis.
Measured: 34 weeks
Secondary outcomes (4)
Safety and tolerability
To investigate the safety and tolerability of TroVax® in combination with Pem/Cis. This will be assessed from toxicity data, SAE reports and dose of chemotherapy received
Measured: 34 weeks
Clinical activity in terms of PFS, ORR and OS
To assess secondary measures of clinical activity, including progression-free survival (PFS), objective response rate (ORR), overall survival (OS) at 6 months and 1 year
Measured: 1 year
Relationship between immune response and clinical response
To explore the relationship between immune response (antibody and cellular responses against the tumour 5T4 and the MVA viral vector) and clinical response (PFS, ORR, OS).
Measured: 1 year
Identify potential predictors of treatment benefit
To investigate the utility of (a) baseline platelet levels, (b) baseline monocyte levels and (c) baseline haemoglobin as predictors of treatment benefit.
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 posted3 Apr 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignantStudies 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wales Cancer Trials Unit
- Sponsor type
- University, hospital or other
- Collaborators
- Velindre NHS Trust, June Hancock Mesothelioma Research Fund, Velindre Cancer Centre Stepping Stones Appeal
- Responsible party
- Sponsor
- Investigators
- Jason F Lester, FRCR, MRCP, Principal investigator, Velindre Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569919
- Sponsor's protocol ID
- 2010/VCC/0049
- Other IDs
- 2010-023230-22
- Acronym
- SKOPOS
- Status last verified
- Mar 2013
- First submitted
- 28 Mar 2012
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Assess the Safety, Immunological Activity of TroVax® Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT01569919
- Acronym / sponsor ID
- SKOPOS / 2010/VCC/0049
- Conditions
- Malignant, Pleural, Mesothelioma
- Keywords
- Phase II, Single arm, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Wales Cancer Trials UnitUniversity, hospital or other
- Collaborators
- Velindre NHS Trust, June Hancock Mesothelioma Research Fund, Velindre Cancer Centre Stepping Stones Appeal
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 3 Apr 2012 (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 study is for patients with malignant mesothelioma of the lung lining (called pleura) who are planning to have pemetrexed-cisplatin chemotherapy.
We are investigating whether giving a vaccine called TroVax® with pemetrexed-cisplatin chemotherapy is both safe and potentially beneficial in patients with mesothelioma. This vaccine has been used in combination with chemotherapy in other types of cancer and has been shown to be safe. Cancer vaccines work by stimulating the person's immune system to fight the disease, in a similar way to the immune system fighting infection. In laboratory experiments, the vaccine has been shown to stimulate an immune response to a particular protein widely found on mesothelioma cells called 5T4. In patients with mesothelioma it is hoped that the vaccine will stimulate the immune system to attack mesothelioma cells carrying the 5T4 protein.
Pemetrexed-cisplatin chemotherapy is currently seen as the best treatment for patients with mesothelioma, and this is why we plan to combine it with the vaccine. It is hoped that the combination of the TroVax® vaccine and chemotherapy is more beneficial than chemotherapy alone.
Pemetrexed-cisplatin will be given into a vein in the arm (intravenously) every 3 weeks. The TroVax® vaccine will be given as an injection into the shoulder muscle (intramuscularly) 3 weeks before chemotherapy starts, one week before chemotherapy starts, then every 3 weeks. Each participant will receive 4 chemotherapy and 9 vaccine treatments if they complete the planned trial schedule. We aim to recruit 26 patients into the trial over a two year period. If this study shows that pemetrexed-cisplatin chemotherapy plus the TroVax® vaccine is safe and beneficial in terms of stimulating the immune system, the combination will be tested further in larger clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TroVax® | Experimental | Biological: TroVax®, Drug: Pemetrexed, Drug: Cisplatin, Dietary Supplement: Vitamin B12, Dietary Supplement: Folic Acid, Drug: DexamethasoneIn this single-arm study, all participants will receive 9 injections of the TroVax® vaccine, plus standard cisplatin and pemetrexed chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed and dated written informed consent obtained from the patient in accordance with the local regulations
- Locally advanced or metastatic, histologically or cytologically proven MPM
- Aged 18 years or over
- WHO performance status 0-1 (Appendix I)
- Life expectancy > 6months
Key exclusion criteria (17 listed)
- Serious infections within the 28 days prior to entry to the trial.
- Prior TroVax® treatment
- Previous chemotherapy for MPM
- Major surgery or radiation therapy completed ≤ 4 weeks prior to enrolment
- Prior radiopharmaceuticals (strontium, samarium) less than 8 weeks prior to enrolment
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 |
|---|---|---|
| TroVax®Dose of 1 x 10^9 TCID 50/ml, in 1ml, given on day 1 of weeks 1, 3, 6, 9, 12, 15, 18, 21, 24. | Biological | TroVax® |
| Pemetrexed500 mg/m^2 over 10 mins, given on day 3 of weeks 4, 7, 10, 13. | Drug | TroVax® |
| Cisplatin75mg/m^2 over 1 hour, given on day 3 of weeks 4, 7, 10, 13 | Drug | TroVax® |
| Vitamin B121000μg intramuscular, Day 2 of weeks 3 and 12 | Dietary supplement | TroVax® |
| Folic Acid400μg oral daily from Day 2 of week 3 to Day 2 of week 16 | Dietary supplement | TroVax® |
| Dexamethasone4mg BD, Days 2-6 of weeks 4, 7, 10, 13 | Drug | TroVax® |
Primary outcome
Immune response to 5T4 and MVA antigens as measured by intracellular cytokine staining (ICCS)
Time frame: 34 weeks
To evaluate whether TroVax® is active in the treatment of MPM. This will be assessed by measuring the cellular or humoral anti-5T4 immune responses following treatment with TroVax® given in combination with Pem/Cis.
4 secondary outcomes
Safety and tolerability
Time frame: 34 weeks
Clinical activity in terms of PFS, ORR and OS
Time frame: 1 year
Relationship between immune response and clinical response
Time frame: 1 year
Identify potential predictors of treatment benefit
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
Related trials for Malignant
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Recruiting
Tele-HOPE: A Telehealth Pharmacist Opioid Patient Education Pilot Study
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Jason F Lester, FRCR, MRCP principal investigator
Velindre Cancer Centre
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 TroVax®, Pemetrexed and Cisplatin in people with Malignant and Pleural, run by Wales Cancer Trials Unit at 1 site 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 11 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 12 Mar 2013. 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 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hayley Clements, BSc (+442920687500, skopos@cardiff.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response to 5T4 and MVA antigens as measured by intracellular cytokine staining (ICCS) (time frame: 34 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 12 Mar 2013.