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Locally Advanced Rectal CancerPhase 2NCT03503630

Short-course Radiation Followed by mFOLFOX-6 Plus COMPOUND 2055269 for Locally-advanced Rectal Adenocarcinoma

A Phase 2 study testing COMPOUND 2055269, Radiation Therapy and mFOLFOX in people with Locally Advanced Rectal Cancer, run by Ali Shamseddine at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to show that the addition of COMPOUND 2055269, an immunotherapeutic drug, to Folfox chemotherapy will improve the pathologic complete response rate in patients with locally advanced rectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Locally Advanced Rectal Cancer
What is being tested?
COMPOUND 2055269, Radiation Therapy and mFOLFOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
3 sitesin 2 countries
Study dates
20 Jul 2018to 2 Jul 2024
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

  • Patients aged ≥18 years.
  • Locally-advanced rectal cancer (cT2 N1-3, cT3 N0-3, evidence of extramural vascular or mesorectal fascia involvement).
  • <12 cm from anal verge.
  • Histologically proven rectal adenocarcinoma.
  • ECOG performance score ≤ 1.
  • Have adequate organ function by meeting the following:
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  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
  • Platelet count ≥ 100 × 109/L;
  • Hemoglobin ≥ 9 g/dL;
  • Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range;
  • AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver);
  • Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft- Gault formula (or local institutional standard method).
  • Negative serum or urine pregnancy test at screening for women of childbearing potential.
  • Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last COMPOUND 2055269 treatment administration if the risk of conception exists.

Who cannot join

  • Distant metastasis (M1).
  • Patients with T2 N0 or T4.
  • Recurrent rectal cancer.
  • Symptoms or history of peripheral neuropathy.
  • Prior radiotherapy or chemotherapy.
  • Current use of immunosuppressive medication, except for the following:
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  • Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intraarticular injection);
  • Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
  • Vaccination within 4 weeks of the first dose of COMPOUND 2055269 and while on trials is prohibited except for administration of inactivated vaccines.
  • Active infection requiring systemic therapy.
  • Known history of testing positive for the human immunodeficiency virus or known acquired immunodeficiency syndrome.
  • Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive).
  • Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).
  • Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
  • Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
  • Prior organ transplantation including allogenic stem-cell transplantation.
  • Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Concurrent treatment with a non-permitted drug.
  • Patients suspected by the physician that he/she will not compliant to the protocol conduct.
  • Pregnant or breastfeeding patients.
  • Patient participating in another clinical trial.
  • Patient who is not willing to sign the consent form.
  • Any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  • Legal incapacity or limited legal capacity patients receiving other oncology specific medication not authorized in the protocol.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Lebanon2 sites

  • American University of Beirut Medical Center

    Beirut

  • Hôtel Dieu de France

    Beirut

Other trials in Lebanon

Jordan1 site

  • King Hussein Cancer Center

    Amman

Other trials in Jordan

About this study

The purpose of this study is to show that the addition of COMPOUND 2055269, an immunotherapeutic drug, to Folfox chemotherapy will improve the pathologic complete response rate in patients with locally advanced rectal cancer.

Read the detailed description

The purpose of this study is to show that the addition of COMPOUND 2055269, an immunotherapeutic drug, to Folfox chemotherapy will improve the pathologic complete response rate in patients with locally advanced rectal cancer.

COMPOUND 2055269 has demonstrated meaningful clinical activity across various tumor types and treatment settings. No clinical trial is conducted over COMPOUND 2055269 in locally-advanced rectal adenocarcinoma.

Being tested
COMPOUND 2055269, Radiation Therapy, mFOLFOX, Total Mesorectal Excision
Keywords
Locally advanced rectal cancer, Immunotherapy, Short course radiation, Folfox, Response rate

What participants receive

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

  • COMPOUND 2055269Drug

    COMPOUND 2055269 to be given every 2 weeks with chemotherapy for 6 cycles

  • Radiation TherapyRadiation

    Radiotherapy 25 Gy to be given on Days 1-5

  • mFOLFOXDrug

    Given every 2 weeks for 6 cycles

  • Total Mesorectal ExcisionProcedure or surgery

    Surgery to be done 2-3 weeks after last cycle of chemotherapy and COMPOUND 2055269

Study groups in NCT03503630
Study groupRoleWhat they receive
Locally advanced rectal cancer patientsExperimental1. Week 1: D1-5: radiotherapy 25 Gy in 5 fractions 2. mFOLFOX-6: Oxaliplatin 85 mg/m2 in a 2-hour infusion Leucovorin 400 mg/m² over 2 hours Bolus fluorouracil 400 mg/m² followed by a 48-hour infusion of fluorouracil 2,400 mg/m² + COMPOUND 2055269 10 mg/kg every 2 weeks (first administration at D15, for a total of 6 cycles) 3. Week 16 or 17 (2 to 3 weeks after last cycle of chemotherapy + COMPOUND 2055269): Total Mesorectal Excision
Receives: Drug: COMPOUND 2055269; Radiation: Radiation Therapy; Drug: mFOLFOX; Procedure: Total Mesorectal Excision

What is being measured

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

  1. The primary objective of the study is to evaluate the pathologic complete response (pCR) rate following short-course radiation then mFOLFOX-6/COMPOUND 2055269

    Will be done via pathologic assessment on the surgical specimen

    Measured: After 17 weeks (once surgery is done)

Secondary outcomes (4)

  1. The proportion of patients who remain progression free at 3 years.

    1. Progression free survival is measured by imaging and serial tumor markers during follow up visits

    Measured: 3 years

  2. PD-L1 expression and T-cell infiltration changes after treatment

    1. PD-L1 \& T cell infiltration is measured by a pathology assessment on day 10 and after surgery

    Measured: At day 10 biopsy and after 17 weeks (once surgery is done)

  3. Number of participants with treatment- related adverse events as assessed by NCI-CTCAE v4.0

    Treatment- related adverse events are assessed by NCI-CTCAE v4.0 in each visit

    Measured: 3 years

  4. Quality of life of the patients in a neoadjuvant setting with COMPOUND 2055269 as assessed by FACT-C questionnaire

    Quality of life is measured via FACT-C questionnaire in each visit.

    Measured: 3 years

Timeline

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

  1. First posted20 Apr 2018
  2. Study start20 Jul 2018
  3. Primary completion15 Mar 2021
  4. Study completion2 Jul 2024 (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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03503630
Sponsor's protocol ID
BIO-2017-0422
Other IDs
MS100070_0021 ISS
Status last verified
Jan 2024
First submitted
29 Mar 2018
Last updated
31 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shamseddine A, Zeidan YH, El Husseini Z, Kreidieh M, Al Darazi M, Turfa R, Kattan J, Khalifeh I, Mukherji D, Temraz S, Alqasem K, Amarin R, Al Awabdeh T, Deeba S, Jamali F, Mohamad I, Elkhaldi M, Daoud F, Al Masri M, Dabous A, Hushki A, Jaber O, Charafeddine M, Geara F. Efficacy and safety-in analysis of short-course radiation followed by mFOLFOX-6 plus avelumab for locally advanced rectal adenocarcinoma. Radiat Oncol. 2020 Oct 7;15(1):233. doi: 10.1186/s13014-020-01673-6.

    PubMed 33028346

  • Shamseddine A, Zeidan YH, Kreidieh M, Khalifeh I, Turfa R, Kattan J, Mukherji D, Temraz S, Alqasem K, Amarin R, Al Awabdeh T, Deeba S, Jamali F, Mohamad I, Elkhaldi M, Daoud F, Al Masri M, Dabous A, Hushki A, Jaber O, Khoury C, El Husseini Z, Charafeddine M, Al Darazi M, Geara F. Short-course radiation followed by mFOLFOX-6 plus avelumab for locally-advanced rectal adenocarcinoma. BMC Cancer. 2020 Sep 1;20(1):831. doi: 10.1186/s12885-020-07333-y.

    PubMed 32873251

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing COMPOUND 2055269, Radiation Therapy and mFOLFOX in people with Locally Advanced Rectal Cancer, run by Ali Shamseddine at 3 sites in 2 countries.

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 14 inclusion and 26 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 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Lebanon, Jordan. 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?

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?

The primary objective of the study is to evaluate the pathologic complete response (pCR) rate following short-course radiation then mFOLFOX-6/COMPOUND 2055269 (time frame: After 17 weeks (once surgery is done)). 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 NCT03503630, which also lists 2 linked publications.

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 31 Jan 2024.

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