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New hope for mesothelioma? drug targets CD30-Positive tumors

NCT ID NCT03007030

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This phase 2 trial tests brentuximab vedotin (Adcetris) in 55 patients with CD30+ malignant mesothelioma that cannot be removed by surgery. The drug is an antibody-drug conjugate designed to seek out and attack cancer cells carrying the CD30 marker. The main goal is to see if the drug can control the disease—shrink tumors or keep them stable—with a target of at least 50% of patients benefiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brentuximab vedotin (Adcetris)
What this could lead to
If successful, this could offer a new treatment option for patients with CD30+ mesothelioma that cannot be surgically removed.
What could go wrong
This is a small, early-phase trial (55 patients) with no control group. The drug may not shrink tumors or improve survival, and side effects like nerve damage or infusion reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

25 people

The number who actually took part.

Started

Apr 2017

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care * Female subject is either: a. post-menopausal for at least one year before the screening visit; or b. surgically sterilized; or c. willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and at least 6 months after the last dose of brentuximab vedotin * Male subject, even if surgically sterilized (i.e., status postvasectomy), agrees to use an acceptable barrier method for contraception (condom with a spermicidal agent), or completely abstain from heterosexual intercourse during the entire study treatment period through 6 months after the last dose of brentuximab vedotin * Absolute neutrophil count (ANC) \> 1500/mm\^3 * Platelets \> 100,000/mm\^3 * Hemoglobin (Hgb) \> 8.5 g/dL * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 3 x ULN; AST and/or ALT may be up to 5 X ULN if with known liver metastases (mets) * Calculated creatinine clearance must be \>= 30 mL/minute * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Pathologic diagnosis of malignant mesothelioma (any primary site is acceptable, any histology is acceptable) * Have unresectable malignant mesothelioma (any histology) * Positive CD30+ immunohistochemical expression * Any line of prior therapy - patients may be chemo-naive or chemo-refractory (any line) * Patients must have measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) or RECIST; examinations for assessment of measurable disease must have been completed within 28 days prior to registration Exclusion Criteria: * Radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25% * Prior allogeneic bone marrow or organ transplantation * Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women * Patient has received other investigational drugs with 14 days before enrollment * Serious medical or psychiatric illness likely to interfere with participation in this clinical study * No prior history of malignancy within 2 years, unless cured of a skin cancer or a stage I-III solid tumor; no prior hematologic malignancy within 3 years * Known hypersensitivity to brentuximab vedotin components * Persons who are incarcerated at time of enrollment (e.g., prisoners) or likely to become incarcerated during the study

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Conditions

The condition(s) this trial relates to.

malignant mesothelioma Mesothelioma, Malignant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.