Rectal CancerPhase 2SPRINTNCT01507103

Tecemotide (L-BLP25) in Rectal Cancer

A Phase 2 study testing Tecemotide (L-BLP25), cyclophosphamide (CPA) and Chemoradiotherapy in people with Rectal Cancer, run by Merck KGaA, Darmstadt, Germany at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of this mechanistic study is to determine the impact of tecemotide (L-BLP25) administration on the mucinous glycoprotein 1 - (MUC1) specific immune response in subjects with newly diagnosed rectal cancer who are eligible for neoadjuvant therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rectal Cancer
What is being tested?: Tecemotide (L-BLP25), cyclophosphamide (CPA) and Chemoradiotherapy
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: 124 participants
Where: 1 siteNetherlands
Study dates: Feb 2012to Jun 2014
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 and female subjects with histologically documented resectable rectal adenocarcinoma in Stage 2-4
Availability of tumor biopsy sufficient for immunological analysis
Indication to receive neoadjuvant concomitant chemoradiotherapy consisting of a radiation dose of 45-52 Gy and capecitabine 825 mg/m^2 orally twice daily. The use of an equivalent schedule based on 5-FU is acceptable
Magnetic resonance imaging small pelvis / computed tomography thorax/abdomen (or X-ray thorax) to document absence of metastatic disease. Imaging must not be older than 6 weeks prior to randomization
Eastern Cooperative Oncology Group performance status of 0 or 1
Written informed consent
Greater than or equal to (>=) 18 years of age

Who cannot join

Previous chemotherapy and/or previous radiotherapy of the pelvic region
Relapsing disease
Previous vaccination with any MUC1 vaccine and other therapeutic cancer vaccines
Previous organ transplantation (bone marrow or solid organs)
Subjects with metastatic disease (except for solitary, resectable liver or lung metastases)
Inadequate hematological function (that is, platelet count less than 140*10^9 per liter [/L], or white blood cell less than 2.5*10^9/L, or hemoglobin less than 90 gram per liter). Clinically significant hepatic dysfunction (that is alanine aminotransferase greater than 2.5*upper limit of normal [ULN], or aspartate aminotransferase greater than 2.5*ULN, or bilirubin greater than 1.5*ULN). Inadequate renal function (that is serum creatinine greater than 1.5*ULN)

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Autoimmune diseases
Recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary or congenital immunodeficiencies
Clinically significant cardiac disease, for example, New York Heart Association Classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by medical history and an electrocardiogram
Other protocol defined exclusion criteria could apply

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

NKI (Nederlands Kanker Instituut)
Amsterdam

Other trials in Netherlands

About this study

Official title: A Multi-center, Randomized, Open-label, Mechanism of Action Trial on the Biological Effects of the Therapeutic Cancer Vaccine Stimuvax® (L-BLP25) in Rectal Cancer Subjects Undergoing Neoadjuvant Chemoradiotherapy

Tecemotide (L-BLP25) is designed to induce an immune response that may lead to immune rejection of tumor tissues that aberrantly express MUC1 antigen. MUC1 is highly expressed in all colorectal cancers and since the adaptive immune system plays a role in the prognosis of rectal cancer, it is reasonable to speculate that tecemotide (L-BLP25) administration might boost the tumor-specific immune response and increase the number of tumor-infiltrating lymphocytes (TILs).

Conditions: Rectal Cancer
Being tested: Tecemotide (L-BLP25), cyclophosphamide (CPA), Chemoradiotherapy
Keywords: Tecemotide (L-BLP25), Cyclophosphamide (CPA), Mode of action, Neoplasms, Neoplasms by Site, Carcinomas, Antineoplastic Agents, Neoadjuvant, Radiotherapy Pharmacologic Actions, Immunosuppressive Agents, Immunologic Function, Therapeutic Uses, Molecular Mechanisms of Pharmacological Action
Medical subject headings: Rectal Neoplasms, Neoplasms, Neoplasms by Site, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tecemotide (L-BLP25)Biological
Also called EMD531444
Subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8, which will be administered concomitantly with the chemoradiotherapy, followed by a 9th subcutaneous injection 7 to 11 days prior to surgery.
cyclophosphamide (CPA)Drug
Also called L01AA01, Endoxana
A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of CPA will be given 3 days before the first tecemotide (L-BLP25) administration.
ChemoradiotherapyOther
Radiotherapy of 45-52 grays (Gy) will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-fluorouracil (5-FU) will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.

Study groups in NCT01507103
Study group	Role	What they receive
Chemoradiotherapy+tecemotide (L-BLP25)+CPA	Experimental	Not described Receives: Biological: Tecemotide (L-BLP25); Drug: cyclophosphamide (CPA); Other: Chemoradiotherapy
Chemoradiotherapy+tecemotide (L-BLP25)	Experimental	Not described Receives: Biological: Tecemotide (L-BLP25); Other: Chemoradiotherapy
Chemoradiotherapy	Active comparator	Not described Receives: Other: Chemoradiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery)
Tumor biopsy samples were collected prior to baseline and after the surgery. The TILs were evaluated in 3 of the most abundant high-power fields (x40) per sample and the mean value considered (after excluding the lowest and the highest value). The tumor immune response was calculated as number of TILs divided by 100 tumor cells.
Measured: Baseline and Week 14 (post-surgery)
Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category
A potential association between MSI status (present or absent) and the primary endpoints (difference from baseline to surgery in CD8+ and CD8+/GrB+ T cell infiltration) was evaluated. Determination of mismatch repair protein (MRP)-expression (hMLH1, hMSH2, hMSH6 and hPMS2) was performed for the detection of the MSI-H-phenotype by IHC and/or on tumor deoxyribonucleic acid (DNA) sample using 5 microsatellite markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27).
Measured: 18 weeks
Change From Baseline in Interferon (IFN)-Gamma Secretion of Mononuclear Cells in Response to MUC1 by Enzyme-linked Immunosorbent Spot (ELISpot) at Post-baseline
IFN-gamma secretion of mononuclear cells in response to MUC1 was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.
Measured: Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)
Change From Baseline in IFN-gamma Secretion of Mononuclear Cells in Response to Carcinoembryonic Antigen (CEA) by ELISpot at Post-baseline
IFN-gamma secretion of mononuclear cells in response to CEA was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.
Measured: Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)

Secondary outcomes (2)

Change From Baseline in Peritumoral Immune Response at Week 14 (Post-surgery)
Immunological changes in the tumor microenvironment were evaluated based on IHC expression of CD3+, CD4+, and Ki67+CD3+ T cells; regulatory T cells (FOXP3+) and myeloid-derived suppressor cells (CD33+CD14-); other immune cells such as NK cells (CD3-CD57+), B cells (CD20+), macrophages (CD68+), and dendritic cells (S100+). Peritumoral immune response was calculated as number of lymphoid cells at the margin of the tumor or in the tumor bed (if there is complete pathological response).
Measured: Baseline and Week 14 (post-surgery)
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial)
Immunological changes in peripheral blood were evaluated based on fluorescence analysis cell sorter phenotypic characterization of T cells (CD3+CD4+ and CD3+CD8+) and of markers of activation and proliferation (CD27, BTLA); and regulatory cells such as CD3+CD4+ (or CD8+) CD45RA+CD25+FoxP3+CD127 T cells. Immunological Response in peripheral blood was measured on a continuous scale.
Measured: Baseline and Week 18 (follow-up / end-of trial)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Jun 2014

First posted10 Jan 2012 (estimated)
Study startFeb 2012
Primary completionJun 2014
Study completionJun 2014

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 Rectal CancerStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01507103
Sponsor's protocol ID: EMR 63325-013
Other IDs: 2011-000847-25
Acronym: SPRINT
Status last verified: Jan 2017
First submitted: 6 Jan 2012
Last updated: 13 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Open-label, Mechanism of Action Trial on the Biological Effects of the Therapeutic Cancer Vaccine Stimuvax® (L-BLP25) in Rectal Cancer Subjects Undergoing Neoadjuvant Chemoradiotherapy
ClinicalTrials.gov ID: NCT01507103
Acronym / sponsor ID: SPRINT / EMR 63325-013
Conditions: Rectal Cancer
Keywords: Tecemotide (L-BLP25), Cyclophosphamide (CPA), Mode of action, Neoplasms, Neoplasms by Site, Carcinomas, Antineoplastic Agents, Neoadjuvant
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 10 Jan 2012 (estimated)
Results: Posted 2 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Chemoradiotherapy+tecemotide (L-BLP25)+CPA	Experimental	Biological: Tecemotide (L-BLP25), Drug: cyclophosphamide (CPA), Other: Chemoradiotherapy
Chemoradiotherapy+tecemotide (L-BLP25)	Experimental	Biological: Tecemotide (L-BLP25), Other: Chemoradiotherapy
Chemoradiotherapy	Active comparator	Other: Chemoradiotherapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male and female subjects with histologically documented resectable rectal adenocarcinoma in Stage 2-4
Availability of tumor biopsy sufficient for immunological analysis
Indication to receive neoadjuvant concomitant chemoradiotherapy consisting of a radiation dose of 45-52 Gy and capecitabine 825 mg/m^2 orally twice daily. The use of an equivalent schedule based on 5-FU is acceptable
Magnetic resonance imaging small pelvis / computed tomography thorax/abdomen (or X-ray thorax) to document absence of metastatic disease. Imaging must not be older than 6 weeks prior to randomization
Eastern Cooperative Oncology Group performance status of 0 or 1

Key exclusion criteria (10 listed)

Previous chemotherapy and/or previous radiotherapy of the pelvic region
Relapsing disease
Previous vaccination with any MUC1 vaccine and other therapeutic cancer vaccines
Previous organ transplantation (bone marrow or solid organs)
Subjects with metastatic disease (except for solitary, resectable liver or lung metastases)

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
Tecemotide (L-BLP25)Also: EMD531444Subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8, which will be administered concomitantly with the chemoradiotherapy, followed by a 9th subcutaneous injection 7 to 11 days prior to surgery.	Biological	Chemoradiotherapy+tecemotide (L-BLP25), Chemoradiotherapy+tecemotide (L-BLP25)+CPA
cyclophosphamide (CPA)Also: L01AA01, EndoxanaA single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of CPA will be given 3 days before the first tecemotide (L-BLP25) administration.	Drug	Chemoradiotherapy+tecemotide (L-BLP25)+CPA
ChemoradiotherapyRadiotherapy of 45-52 grays (Gy) will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-fluorouracil (5-FU) will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.	Other	Chemoradiotherapy, Chemoradiotherapy+tecemotide (L-BLP25), Chemoradiotherapy+tecemotide (L-BLP25)+CPA

Primary outcome

Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery)
Time frame: Baseline and Week 14 (post-surgery)
Tumor biopsy samples were collected prior to baseline and after the surgery. The TILs were evaluated in 3 of the most abundant high-power fields (x40) per sample and the mean value considered (after excluding the lowest and the highest value). The tumor immune response was calculated as number of TILs divided by 100 tumor cells.
Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category
Time frame: 18 weeks
A potential association between MSI status (present or absent) and the primary endpoints (difference from baseline to surgery in CD8+ and CD8+/GrB+ T cell infiltration) was evaluated. Determination of mismatch repair protein (MRP)-expression (hMLH1, hMSH2, hMSH6 and hPMS2) was performed for the detection of the MSI-H-phenotype by IHC and/or on tumor deoxyribonucleic acid (DNA) sample using 5 microsatellite markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27).
Change From Baseline in Interferon (IFN)-Gamma Secretion of Mononuclear Cells in Response to MUC1 by Enzyme-linked Immunosorbent Spot (ELISpot) at Post-baseline
Time frame: Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)
IFN-gamma secretion of mononuclear cells in response to MUC1 was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.
Change From Baseline in IFN-gamma Secretion of Mononuclear Cells in Response to Carcinoembryonic Antigen (CEA) by ELISpot at Post-baseline
Time frame: Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)
IFN-gamma secretion of mononuclear cells in response to CEA was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.

2 secondary outcomes

Change From Baseline in Peritumoral Immune Response at Week 14 (Post-surgery)
Time frame: Baseline and Week 14 (post-surgery)
Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial)
Time frame: Baseline and Week 18 (follow-up / end-of trial)

Results and safety

Results posted to the registry on 2 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chemoradiotherapy+Tecemotide (L-BLP25)+CPA	41	41
Chemoradiotherapy+Tecemotide (L-BLP25)	41	41
Chemoradiotherapy	42	42

Primary outcome: Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery)

Time frame: Baseline and Week 14 (post-surgery). Mean (Standard Deviation). Unit: TILs per 100 tumor cells

Measure	Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide n = 27	Chemoradiotherapy+Tecemotide (L-BLP25) n = 33	Chemoradiotherapy n = 30
CD8+ (n=23, 27, 26)	0.609 (5.4241)	0.543 (4.5009)	1.538 (3.9509)
CD8+/GrB+ (n=23, 27, 26)	0.565 (3.1646)	0.216 (2.4187)	0.936 (2.7649)

Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide vs Chemoradiotherapy: Effect estimate: -0.04 (95% CI -0.72 to 0.65), p = 0.794, type III SS F-test
Chemoradiotherapy+Tecemotide (L-BLP25) vs Chemoradiotherapy: Effect estimate: -0.20 (95% CI -0.82 to 0.43), p = 0.794, type III SS F-test
Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide vs Chemoradiotherapy+Tecemotide (L-BLP25): Effect estimate: 0.16 (95% CI -0.49 to 0.82), p = 0.794, type III SS F-test

Population analysed: Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analyzed for each category.

Primary outcome: Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category

Time frame: 18 weeks. Number. Unit: subjects

Measure	Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide n = 27	Chemoradiotherapy+Tecemotide (L-BLP25) n = 33	Chemoradiotherapy n = 30
No	25	32	30
Yes	2	1	0

Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide vs Chemoradiotherapy: LS Means estimate: -0.03 (95% CI -0.73 to 0.67), p = 0.921, type III SS F-test
Chemoradiotherapy+Tecemotide (L-BLP25) vs Chemoradiotherapy: LS Means estimate: -0.20 (95% CI -0.83 to 0.44), p = 0.921, type III SS F-test
Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide vs Chemoradiotherapy+Tecemotide (L-BLP25): LS Means estimate: 0.17 (95% CI -0.50 to 0.83), p = 0.921, type III SS F-test

Primary outcome: Change From Baseline in Interferon (IFN)-Gamma Secretion of Mononuclear Cells in Response to MUC1 by Enzyme-linked Immunosorbent Spot (ELISpot) at Post-baseline

Time frame: Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)

Population analysed: Data were not analyzed as no acceptable ELISpot assay is available

Primary outcome: Change From Baseline in IFN-gamma Secretion of Mononuclear Cells in Response to Carcinoembryonic Antigen (CEA) by ELISpot at Post-baseline

Time frame: Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)

Population analysed: Data were not analyzed as no acceptable ELISpot assay is available

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Date of first signature of informed consent until the Follow-up/End-of-Trial visit (Week 18).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chemoradiotherapy+Tecemotide (L-BLP25)+CPA	10 of 39 (25.6%)	38 of 39 (97.4%)	Not reported
Chemoradiotherapy+Tecemotide (L-BLP25)	10 of 41 (24.4%)	41 of 41 (100%)	Not reported
Chemoradiotherapy	12 of 42 (28.6%)	41 of 42 (97.6%)	Not reported

Limitations and caveats (from the sponsor): Not all efficacy data were analyzed as no acceptable ELISpot assay is available. The Sponsor decided to discontinue the development of tecemotide (L-BLP25) in September 2014

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Barbara Guenther study director

Merck KGaA, Darmstadt, Germany

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 Tecemotide (L-BLP25), cyclophosphamide (CPA) and Chemoradiotherapy in people with Rectal Cancer, run by Merck KGaA, Darmstadt, Germany at 1 site in Netherlands.

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 7 inclusion and 10 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 13 Jan 2017. 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 Netherlands. 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 2 Jun 2016). 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?

Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery) (time frame: Baseline and Week 14 (post-surgery)). The study lists 4 primary outcomes in all. 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 NCT01507103.

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 13 Jan 2017.