Brain MetastasisPhase 1NCT07655583
OBSERVE: A Pilot Study Of Omission Of Brain Metastasis Stereotactic Radiosurgery Following Resection With CNS-Active Systemic Therapy
A Phase 1 study testing Systemic therapy in people with Brain Metastasis and Stereotactic Radiosurgery, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To remove a brain tumor, patients usually receive radiation to lower the chance that the cancer will come back in the spot where the tumor was removed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasis, Stereotactic Radiosurgery, Resection
- What is being tested?
- Systemic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2026to 30 Jun 2030
- Phase
- Phase 1
- 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
None listed.
Who cannot join
- History of known leptomeningeal involvement (radiographic or cytological).
- Subjects that have previously received or are currently planned for whole brain radiotherapy.
- Prior unacceptable toxicity on one or more of the agents comprising the planned study systemic therapy.
- Cognitively impaired subjects with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.
- Participant unable to receive a brain MRI (implanted metal devices or foreign bodies) or MRI contrast.
- Pregnancy or plans to become pregnant during the duration of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Thomas H Beckham, MD, 281-217-2904, thbeckham@mdanderson.org
Thomas H Beckham, MD
About this study
To remove a brain tumor, patients usually receive radiation to lower the chance that the cancer will come back in the spot where the tumor was removed.
Read the detailed description
Primary Objective To estimate the risk of surgical bed recurrence of resected melanoma or NSCLC brain metastases treated with highly CNS-active systemic therapy without post-operative radiation.
- Being tested
- Systemic therapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic therapyOther
Systemic therapy regimen consisting of one of the following: dual-agent immune checkpoint inhibitors (e.g. ipilimumab and nivolumab) for melanoma, osimertinib for EGFR Mutant NSCLC, and brigatinib, alectinib, or lorlatinib for ALK rearranged/fusion positive NSCLC.
| Study group | Role | What they receive |
|---|---|---|
| systemic therapy | Experimental | * Begin CNS active systemic therapy as recommended by your oncologist within 5 weeks after surgery.
* Attend study visits every 12 weeks during Years 1 and 2.
* Participate in 4 neurocognitive function assessments in specific windows of time.
* Beyond 2 years, your medical records will continue to be reviewed to look at your health status, unless the participant withdraw or are withdrawn earlier. Receives: Other: Systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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.
- First posted18 Jun 2026
- Study start27 May 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas H Beckham, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655583
- Sponsor's protocol ID
- 2026-0345
- Other IDs
- NCI-2026-04559
- Status last verified
- Sep 2026
- First submitted
- 15 Jun 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBSERVE: A Pilot Study Of Omission Of Brain Metastasis Stereotactic Radiosurgery Following Resection With CNS-Active Systemic Therapy
- ClinicalTrials.gov ID
- NCT07655583
- Acronym / sponsor ID
- 2026-0345
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To remove a brain tumor, patients usually receive radiation to lower the chance that the cancer will come back in the spot where the tumor was removed.
Detailed description
Primary Objective To estimate the risk of surgical bed recurrence of resected melanoma or NSCLC brain metastases treated with highly CNS-active systemic therapy without post-operative radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| systemic therapy | Experimental | Other: Systemic therapy* Begin CNS active systemic therapy as recommended by your oncologist within 5 weeks after surgery. * Attend study visits every 12 weeks during Years 1 and 2. * Participate in 4 neurocognitive function assessments in specific windows of time. * Beyond 2 years, your medical records will continue to be reviewed to look at your health status, unless the participant withdraw or are withdrawn earlier. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- History of known leptomeningeal involvement (radiographic or cytological).
- Subjects that have previously received or are currently planned for whole brain radiotherapy.
- Prior unacceptable toxicity on one or more of the agents comprising the planned study systemic therapy.
- Cognitively impaired subjects with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.
- Participant unable to receive a brain MRI (implanted metal devices or foreign bodies) or MRI contrast.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic therapySystemic therapy regimen consisting of one of the following: dual-agent immune checkpoint inhibitors (e.g. ipilimumab and nivolumab) for melanoma, osimertinib for EGFR Mutant NSCLC, and brigatinib, alectinib, or lorlatinib for ALK rearranged/fusion positive NSCLC. | Other | systemic therapy |
Primary outcome
safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas H Beckham, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Systemic therapy in people with Brain Metastasis and Stereotactic Radiosurgery, 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 0 inclusion and 6 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 15 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Thomas H Beckham, MD ((281) 217-2904, thbeckham@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and adverse events (AEs). (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?
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 15 Sep 2026.