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Oesophageal CancerPhase 2CALIBRATIONNCT03653052

Do Changes in ctDNA Predict Response for Patients With Oesophageal Cancer Receiving Durvalumab

A Phase 2 study testing Durvalumab in people with Oesophageal Cancer, run by Simon C Pacey, MD at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Patients with cancer are increasingly being treated with drugs designed to modulate the response of their immune system, broadly to boost their body's defences against cancer. However, there is an unmet need to identify which patients are unlikely to benefit. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oesophageal Cancer
What is being tested?
Durvalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited Kingdom
Study dates
30 Oct 2018to Jun 2026
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

  • Provide written, informed consent to participate
  • Aged ≥ 18 years at time of consent
  • Confirmed advanced oesophageal cancer for which the patient must have received at least one prior line of standard of care treatment
  • Predicted life expectancy ≥ 3 months
  • Eastern Cooperative Oncology Group (ECOG) PS 0 or 1
  • Measurable disease, as defined by RECIST v1.1.
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  • In the investigator's opinion, have an accessible and biopsiable tumour lesion for additional research biopsy, to which the patient will have to consent at screening.
  • Adequate hematologic and organ function, defined by:
  • ANC ≥ 1500 cells/μL (no GCSF support 2 weeks prior to trial entry)
  • Platelet count ≥ 100,000/μL
  • Haemoglobin ≥ 9.0 g/dL
  • AST or ALT ≤ 2.5 times the upper limit of normal (ULN), (except patients with documented liver metastases where AST and/or ALT can be ≤ 5×ULN)
  • Serum bilirubin ≤1.5 × ULN. (Except patients with confirmed Gilbert's syndrome)
  • INR and APTT ≤ 1.5×ULN.
  • Calculated creatinine clearance (CrCl) ≥ 40 mL/min (Cockcroft-Gault formula)
  • Negative pregnancy test in women of child-bearing potential or evidence of postmenopausal status

Who cannot join

  • Weight of ≤30kg
  • Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
  • Participation in other clinical trials involving active treatment for the malignant disease.
  • Received radiotherapy treatment on a wide body field, or an equivalent to more than 30% of the bone marrow, within the last 4 weeks.
  • Any unresolved symptom NCI CTCAE Grade ≥2 from previous anticancer therapy (with the exception of alopecia and vitiligo).
  • Active or prior documented autoimmune or inflammatory disease (except vitiligo) within the last 3 years, for example:
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  • Intestinal: Inflammatory Bowel Disease (Colitis, Crohn's Disease), Diverticulitis (with the exception of Diverticulosis), Coeliac Disease, Irritable Bowel Disease
  • Vascular: any type of Vasculitic disorder, i.e.: Wegner syndrome.
  • Endocrine: any endocrine alteration related to an auto-immune process i.e.: Hashimoto syndrome. NOTE: patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement treatment may be included at the discretion of the CI.
  • Respiratory: Active Pneumonitis (of any origin: inflammatory or infectious), Sarcoidosis.
  • Dermatological: Psoriasis, Lupus/SLE.
  • Other: Rheumatoid Arthritis, Hypophysitis, Uveitis.
  • History of organ transplant that requires use of immunosuppressive medications or any medical condition in which immunosuppressive agents were administered, including but, not limited to:
  • Systemic corticosteroids.
  • Methotrexate, azathioprine
  • Tumour necrosis factor alpha (TNF-α) blockers
  • History of active primary immunodeficiency.
  • Receipt of live, attenuated vaccine within the last 30 days.
  • Other invasive malignancy within the last 3 years. Patients with previous history of malignancies with a negligible risk of metastasis or death and treated with expected curative intent are eligible at the investigator's discretion, for example:
  • Carcinoma in situ of the cervix
  • Basal or squamous cell skin cancer
  • Localized low to intermediate risk prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse; or prostate cancer (Stage T1/T2a, Gleason ≤ 6 and PSA < 10 ng/mL) undergoing active surveillance and treatment naive
  • Women who are pregnant or lactating/ breast feeding.
  • Male or female patients with reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab.
  • Uncontrolled intercurrent illness, including but not limited to, on-going or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • Brain metastases unless asymptomatic, treated and stable and not requiring steroids in the last 4 weeks. Patients with known or suspected brain metastases at screening should have a CT/ MRI of the brain prior to trial entry.
  • History of leptomeningeal carcinomatosis.
  • Active infection or use of antibiotics (ATB) 14 days prior to Cycle 1 Day 1 of treatment. Patients receiving prophylactic treatment are eligible.
  • Active infection including tuberculosis (clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or known human immunodeficiency virus (positive HIV1/2 antibodies).
  • Subjects with a past or resolved HBV infection (defined as: presence of hepatitis B core antibody -anti-HBc- and absence of hepatitis B surface antigen -HbsAg-) are eligible.
  • Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Major surgical procedure (investigator defined) within 4 weeks prior to first dose or anticipation of the need for a major surgical procedure during the course of the trial other than for diagnosis.
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to durvalumab or any of its excipients, chimeric or humanized antibodies or fusion proteins.
  • Patients previously treated with immune (checkpoint inhibition) therapy
  • Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical trial due to safety concerns, compliance with clinical trial procedures or interpretation of trial results.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

Other trials in United Kingdom

About this study

Official title: CALIBRATION: An Exploratory Study in Patients With Advanced Oesophageal Malignancies Receiving MEDI4736 (Durvalumab), Investigating Whether Early Changes in Circulating Tumour DNA Can Predict Tumour Response

Patients with cancer are increasingly being treated with drugs designed to modulate the response of their immune system, broadly to boost their body's defences against cancer. However, there is an unmet need to identify which patients are unlikely to benefit. Deciding on benefit from therapy uses standard imaging methods (e.g. CT scans), which can take time (months) whereas DNA in the bloodstream could be measured more rapidly.

The main aim of this study is to assess whether changes in the level of circulating tumour DNA (ctDNA) can quickly determine a patients response. This would enable patients to change therapies more quickly if they are not responding and reduce exposure to unnecessary side effects.

Read the detailed description

Measuring circulating (plasma) tumour DNA has been described as a 'liquid biopsy' able to study a tumour without invasive biopsy. By measuring ctDNA at different time points the investigators can detect tumour changes that indicate if the patient is responding to treatment or not.

This trial has been designed as a prospective, open label, non-randomised trial where patient with advanced oesophageal cancer will be treated with MEDI4736 (durvalumab), a drug designed to alter the immune system response. Samples will be taken to regularly to measure ctDNA levels and compared to patients response at 6 months when undergoing standard CT scans.

The study will run at a single centre (Addenbrookes Hospital, Cambridge). Nineteen, evaluable, patients will receive durvalumab until progression while detailed studies will assess their tumour and immune response.

Being tested
Durvalumab
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • DurvalumabDrug

    Also called MEDI4736

    Durvalumab will be administered via an infusion in the arm, over a duration of up to 1 hour.

Study groups in NCT03653052
Study groupRoleWhat they receive
DurvalumabExperimentalPatients with advanced oesophageal cancer will be administered with 1500mg of durvalumab once every 4 weeks for up to 6 months.
Receives: Drug: Durvalumab

What is being measured

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

  1. Clinical response to therapy (durvalumab)

    Changes in ctDNA levels (from baseline to C1/C2) compared with objective RECIST radiological response at 26 weeks

    Measured: 26 weeks

Timeline

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

  1. First posted31 Aug 2018
  2. Study start30 Oct 2018
  3. Primary completion11 Nov 2021
  4. Study completionJun 2026 (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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03653052
Sponsor's protocol ID
CALIBRATION
Acronym
CALIBRATION
Status last verified
Apr 2025
First submitted
9 Jul 2018
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab in people with Oesophageal Cancer, run by Simon C Pacey, MD 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 16 inclusion and 35 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2025. 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?

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?

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?

Clinical response to therapy (durvalumab) (time frame: 26 weeks). 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 NCT03653052.

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 24 Apr 2025.

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