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Rectum CancerPhase 2PEMRECNCT04109755

Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer

A Phase 2 study testing Pembrolizumab in people with Rectum Cancer and Rectal Cancer, run by University Hospital, Geneva at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This project investigates the clinical and biological impact of combining immunotherapy (pembrolizumab) with short course radiotherapy (5Gy, five times) in the neo-adjuvant treatment of localised microsatellite stable (MSS) rectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectum Cancer, Rectal Cancer
What is being tested?
Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteSwitzerland
Study dates
2 Jun 2020to Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of rectal adenocarcinoma will be enrolled in this study.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation.
  • Patients with previously untreated localized T3-T4 N0 or T any or N1-2, M0 rectal adenocarcinoma.
  • Tumour must be microsatellite stable (MSS).
  • A multi-disciplinary tumour board should recommend neo-adjuvant short course radiotherapy and surgery.
  • Have provided archival tumour tissue sample or newly obtained core or excisional biopsy of a tumour lesion not previously irradiated. Formalin-fixed paraffin embedded (FFPE) tissue blocks are preferred.
  • Have adequate organ function as defined in the following table. Specimens must be collected within 10 days prior to the start of study treatment.

Who cannot join

  • Has a microsatellite instable tumour (MSI-High).
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
  • Has received for the same disease prior systemic anti-cancer therapy including investigational agents prior to starting pembrolizumab. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
  • Has received prior radiotherapy for the same disease. If treated with radiotherapy for another disease, participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
  • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
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  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • 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.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a known history of Human Immunodeficiency Virus (HIV).
  • Has a known history of Hepatitis B virus (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA > 1.5E1 is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Thibaud Kössler, MD PhD contact

+41 (0)22 372 77 68

thibaud.kossler@hcuge.ch

Sandra Bettinelli Riccardi, PhD contact

+41223722903

Sandra.BettinelliRiccardi@hcuge.ch

Switzerland1 site, 1 recruiting

  • Hôpitaux Universitaires de Genève

    Geneva, 1205

    Thibaud Kössler, MD PhD, thibaud.kossler@hcuge.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: A Phase II Study to Evaluate Safety and Efficacy of Neo-adjuvant Pembrolizumab and Radiotherapy in Localised MSS Rectal Cancer

This project investigates the clinical and biological impact of combining immunotherapy (pembrolizumab) with short course radiotherapy (5Gy, five times) in the neo-adjuvant treatment of localised microsatellite stable (MSS) rectal cancer.

Being tested
Pembrolizumab
Keywords
Rectal cancer, Immunotherapy, Short course radiotherapy, 5x5Gy, Pembrolizumab, Localised rectal cancer
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • PembrolizumabDrug

    5x5 Gy radiotherapy in 1 week, 4 cycles of Pembrolizumab (200 mg every three week), surgery

Study groups in NCT04109755
Study groupRoleWhat they receive
ExperimentalExperimentalShort Course Radiation Therapy (5 x 5 Gy in 1 week, SCRT) with 4 injections of Pembrolizumab starting on the first day of radiotherapy and surgery
Receives: Drug: Pembrolizumab

What is being measured

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

  1. Tumour regression grade

    To assess the tumour regression grade (TRG) after short course radiotherapy when given together with pembrolizumab, using the Mandard regression grade score

    Measured: 12 weeks after start

Secondary outcomes (7)

  1. Tolerability and safety

    To assess tolerability and safety of pembrolizumab given with short course radiotherapy before surgery, using the common terminology criteria for adverse events (CTCAE) Version 4.0

    Measured: 5 years

  2. Overall Survival

    To estimate overall survival (OS), defined as the time between the date of the study entry and the date of death due to any cause. Subjects who have not died at the time of last known follow-up will be censored.

    Measured: 5 years

  3. Disease-free survival

    To estimate disease-free survival (DFS), defined as the time between the date of the study entry and the date of recurrence, second primary cancer, or death without evidence of recurrence or second primary cancer.

    Measured: 3 years

  4. Locoregional relapse-free survival

    To estimate locoregional relapse-free survival (LRRFS), defined as the time between the date of the surgery and local or regional recurrence. LRRFS is evaluated in patients who had an R0 resection only

    Measured: 5 years

  5. Distant metastasis-free survival

    To estimate distant metastasis-free survival (DMFS), defined as the time between the date of the surgery and metastatic recurrence.

    Measured: 5 years

  6. EORTC QLQ-C30

    European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-C30

    Measured: 30 months

  7. EORTC QLQ-CR29

    European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-CR29

    Measured: 30 months

Timeline

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

  1. First posted30 Sep 2019
  2. Study start2 Jun 2020
  3. Primary completionJun 2022 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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 (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04109755
Sponsor's protocol ID
PEMREC
Acronym
PEMREC
Status last verified
Sep 2021
First submitted
24 Sep 2019
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Corro C, Buchs NC, Tihy M, Durham-Faivre A, Bichard P, Frossard JL, Puppa G, McKee T, Roth A, Zilli T, Trembleau C, Di Marco M, Dutoit V, Dietrich PY, Ris F, Koessler T. Study protocol of a phase II study to evaluate safety and efficacy of neo-adjuvant pembrolizumab and radiotherapy in localized rectal cancer. BMC Cancer. 2022 Jul 15;22(1):772. doi: 10.1186/s12885-022-09820-w.

    PubMed 35840912

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Rectum Cancer and Rectal Cancer, run by University Hospital, Geneva at 1 site in Switzerland.

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 18 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: looking for participants now, as of the sponsor's last update on 30 Sep 2021. 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 Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thibaud Kössler, MD PhD (+41 (0)22 372 77 68, thibaud.kossler@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumour regression grade (time frame: 12 weeks after start). 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 NCT04109755, 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 30 Sep 2021.

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