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ChordomaPhase 2NCT05041127

Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma

A Phase 2 study testing Cetuximab and Questionnaire Administration in people with Chordoma and Metastatic Chordoma, run by M.D. Anderson Cancer Center at 1 site in United States.

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

This is a multicenter, single arm, phase 2 study designed to evaluate the efficacy and safety of cetuximab for the treatment of advanced (unresectable)/metastatic, chordoma. The target patient population will be any chordoma patient 18 years of age with locally unresectable disease or metastatic disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cetuximab and Questionnaire Administration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
27 May 2022to 1 Sep 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

  • Age ≥ 18 years
  • Histologically confirmed diagnosis of chordoma which is advanced (unresectable) and/or metastatic
  • ECOG Performance Status of ≤ 2
  • At least one site of measurable disease on x-ray/CT/MRI and/or PET/CT scan as defined by RECIST 1.1 criteria. Baseline imaging must be performed within 30 days of Day 1 of study.
  • Adequate organ function within 28 days of Day 1 of study defined as:
  • The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥ 1000/µL, hemoglobin ≥ 9 g/dL (5.58 mmol/L), and platelets ≥ 100,000/µL
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  • The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg/dL (25.65 μmol/L) (NOTE: Patients with elevated bilirubin secondary to Gilbert's disease are eligible to participate in the study), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper Page 26 limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases).
  • The patient has adequate renal function as defined by a serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed). 3.1.6 Patients may have any prior line of therapy, but there should a washout period of at least 3 weeks from any systemic therapy (small molecule/targeted agents, immunotherapies) and/or radiation therapy.
  • Patients should be completely recovered from any reversible toxicities associated with any prior therapies.
  • There should be access of archival tumor tissue for central pathology review, or a new tumor related biopsy should be considered within acceptable risk to the patient.
  • Patients must have no prior history of use of an EGFR inhibitor for treatment of their chordoma
  • Because the teratogenicity of cetuximab is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative serum pregnancy test ≤ seven days prior to Day 1 of study.
  • Life expectancy of > 3 months

Who cannot join

  • Prior use of an EGFR inhibitor for treatment of their chordoma
  • Non-metastatic, resectable disease
  • No measurable disease according to RECIST 1.1
  • Life expectancy of less than 3 months
  • Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured.
  • Concomitant participation to another clinical trial with active agent during the study (concomitant non-interventional study will be allowed) Page 27
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  • Patients who have a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab, red meat allergy, or tick bite history
  • Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
  • The patient has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.
  • The patient has uncontrolled or poorly-controlled hypertension (>180 mmHg systolic or > 130 mmHg diastolic.
  • Major surgery within 4 weeks prior to Day 1 of study or who have not recovered adequately from prior surgery
  • Patients who have received wide field radiotherapy ≤ 3 weeks or limited field radiation for palliation < 3 weeks prior to Day 1 of study or who have not recovered adequately from side effects of such therapy
  • Patients who have received any prior systemic therapy < 3 weeks prior to Day 1 of study or have not recovered adequately from toxicities to the baseline.
  • Women who are pregnant or nursing/breastfeeding.
  • Inability to comply with protocol required procedures such as Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II Trial of Cetuximab for Patients With Advanced or Metastatic Chordoma

This is a multicenter, single arm, phase 2 study designed to evaluate the efficacy and safety of cetuximab for the treatment of advanced (unresectable)/metastatic, chordoma. The target patient population will be any chordoma patient 18 years of age with locally unresectable disease or metastatic disease.

Read the detailed description

Primary Objective:

  • To evaluate the efficacy of cetuximab in patients with advanced (unresectable) or metastatic, chordoma based on response rate according to RECIST1.1.

Secondary Objectives:

  • To evaluate response rate according to Choi criteria
  • To evaluate the safety and tolerability of cetuximab for chordoma patients
  • To evaluate the progression-free survival (median, at 24 weeks, and 52 weeks) and to determine the overall survival (median).
  • To evaluate the ratio of PFS on study compared to PFS from prior treatment
Being tested
Cetuximab, Questionnaire Administration
Medical subject headings
Chordoma

What participants receive

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

  • CetuximabBiological

    Also called Cetuximab Biosimilar CDP-1, Cetuximab Biosimilar CMAB009, Cetuximab Biosimilar KL 140, Chimeric Anti-EGFR Monoclonal Antibody

    Given IV

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT05041127
Study groupRoleWhat they receive
Treatment (cetuximab)ExperimentalPatients receive cetuximab IV over 60-120 minutes QW in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Cetuximab; Other: Questionnaire Administration

What is being measured

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

  1. Overall response rate

    Measured by Response Evaluation Criteria in Solid Tumors 1.1. Will be estimated based on a binomial portion expressed as percentage with 95% confidence intervals.

    Measured: through study completion, an average of 1 year

Timeline

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

  1. First posted10 Sep 2021
  2. Study start27 May 2022
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05041127
Sponsor's protocol ID
2020-0217
Other IDs
NCI-2020-14259, 2020-0217
Status last verified
Sep 2026
First submitted
2 Sep 2021
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab and Questionnaire Administration in people with Chordoma and Metastatic Chordoma, run by M.D. Anderson Cancer Center at 1 site in United States.

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 13 inclusion and 15 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 4 Sep 2026. 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 States. 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?

Overall response rate (time frame: through study completion, an average of 1 year). 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 NCT05041127.

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 4 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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