Soft-tissue SarcomaPhase 1/2NCT03602833
Phase I Study Compound 451238 and Radiotherapy in Soft-tissue Sarcoma
A Phase 1/2 study testing Compound 451238 in people with Soft-tissue Sarcoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The objective of this trial is to assess the safety and tolerability of combining compound 451238 and radiotherapy, treating advanced STS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft-tissue Sarcoma
- What is being tested?
- Compound 451238
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2018to 30 Jun 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 must have a diagnosis of soft tissue sarcoma with at least 2 metastases not suitable for cure using conventional treatments. At least one lesion must be suitable to receive palliative radiotherapy. The radiation tumour target volume must be between the neck and the diaphragm in the thorax, trunk of an extremity.
- Histological confirmed diagnosis of soft-tissue sarcoma .
- Age ≥ 18 years.
- Life expectancy of > 12 weeks.
- At least one site of accessible disease of pre- and post-treatment core biopsies.
- At least two sites of measurable disease on CT
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- ECOG Performance Status of ≤ 1.
- Adequate bone marrow function
- Adequate renal function defined by an estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula.
- Adequate liver function.
- Written, voluntary informed consent.
- Patients may have received ≥ 1 or more lines systemic therapies. Women of childbearing potential (WOCBP) and male partners of WOCBP must agree to use 2 highly effective methods of contraception from giving informed consent for a period of 28 days prior to administration of first dose of compound 451238, throughout treatment with compound 451238 and for at least 60 days after treatment. 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 pregnancy test ≤ 72 hours prior to Day 1 of study as defined in section 7.3.7.
- 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 pregnancy test ≤ 72 hours prior to Day 1 of study as defined in section 7.3.7. See CTFG Contraception Guidance 15.09.2015.
- Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or 10 mg equivalent prednisone per day
- Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable.
- Patients with a contraindication to MRI (standard of care imaging for extremity disease only) can be entered into the study and will have CT based RECIST 1.1 assessments.
- In patients who have symptoms, when assessed using CTCAE v.4.0, these are of grade 0 or 1 severity only.
Who cannot join
- Systemic chemotherapy within 28 days prior to study entry.
- Prior systemic therapy.
- Patients who are curable by conventional multidisciplinary management.
- Patients with known central nervous system metastatic disease are ineligible for enrollment.
- 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.
- Patients who have received radiotherapy ≤ 4 weeks prior to Day 1 of study or who have not recovered adequately from side effects.
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- Previous radiotherapy within the treatment area.
- Patients who have active infections requiring therapy.
- Patients with a history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C. Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive.
- Patients that have a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
- Patients who received systemic anti-cancer treatment prior to the first dose of study drug within the following time frames:
- Patients who have received biologic therapy within 4 weeks.
- Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug
- Patients with active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Patients that require inhaled steroids or local steroid injections would not be excluded from the study. Patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded from the study.
- Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (eg, intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication). xvi. Active autoimmune disease that might deteriorate. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
- Prior organ transplantation including allogenic stem-cell transplantation.
- Current severe acute or chronic colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
- Women who are pregnant or nursing/breastfeeding.
- Known hypersensitivity to compound 451238.
- Patients with a history of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease.
- 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.
- Patients requiring steroid replacement doses above physiological requirements will be considered ineligible for this study: allowed up to 20 mg hydrocortisone (or 5 mg of prednisolone) in the morning and 10 mg hydrocortisone (or 2.5 mg prednisolone) in the evening.
- Patients with the risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess, abdominal carcinomatosis).
- Patients who have received a live vaccine within 30 days prior to the first dose of trial treatment.
- Previous malignant disease within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
- 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. xxviii. Patients on anticoagulation medication.
- Patients who have symptoms, which when assessed using CTCAE v.4.0, are of grade 2 severity or above.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: Compound 451238 and Radiotherapy in Soft-tissue Sarcoma
The objective of this trial is to assess the safety and tolerability of combining compound 451238 and radiotherapy, treating advanced STS.
Read the detailed description
Overall Study Design
This is a single centre open label, non-randomized, non-placebo phase 1 clinical trial to establish the safety and tolerability compound 451238 in combination with radiotherapy in patients with soft tissue sarcomas (STS). STS patients receiving radiotherapy to a tumour deposit above the diaphragm in the thorax, trunk or extremity, will receive radiotherapy. This study will recruit 12 patients and run as a fixed dose trial. Patients will continue on the treatment regimen unless they progress, suffer unacceptable toxicities, or withdraw from the trial.
Treatment Regimen
A maximum of 12 patients will be recruited. The safety and tolerabilty will be assessed in the first 3+3 patients with expansion to 12 patients as tolerated. All patients will be treated at the same fixed dose level of 10mg/kg, administered intravenously once every two weeks. A minimum gap of 2 weeks will be left between treatment of the first and second patient (with the combination of RT) to mitigate against multiple patients suffering acute toxicity. Patients will be followed for a minimum of 11 weeks from the initiation of radiotherapy with combined compound 451238 for the purposes of acute toxicity monitoring. Late toxicity monitoring will commence from 11 weeks + one day from initiation of radiotherapy with combined compound 451238 and continue until disease progression or initiation of new anti-cancer therapy.
Safety Follow-up - 30 Days
All patients will be required to attend a safety follow-up visit 30 days after the last dose of compound 451238 or before the initiation of a new anti-cancer treatment, whichever comes first.
Extended Safety Follow-up - 90 Days
Given the potential risk for delayed toxicities, an extended safety follow-up visit must be performed up to 90 days after the last dose of compound 451238 administration. The extended safety follow-up will be performed either via a site visit or via a telephone call with subsequent site visit requested in case any concerns noted during the telephone call. All AEs and SAEs that occur prior to the safety follow-up visit should be reported as described in the trial protocol. After the safety follow-up any unresolved AEs at the patient's last visit should be followed up for as long as medically indicated, but without further recording in the CRF.
Follow-up
Patients who discontinue trial treatment for any reason other than disease progression will move into the follow-up phase and will be assessed every 12 weeks by MRI or radiologic imaging to monitor disease status. Every effort will be made to collect information regarding disease status until the start of new anti-cancer therapy, disease progression, death, withdrawal or end of the study. Information regarding post-study anticancer treatment will be collected if new treatment is initiated.
Survival Follow-up
Once a patient experiences confirmed PD or starts a new anti-cancer therapy, the patient moves into the survival follow-up phase and will be followed up every 12 weeks to determine their disease status. This will be done by reviewing their medical notes and/or contacting the patient and/or General Practitioner directly. Patients will remain on this follow-up until death, withdrawal of consent, or the end of the study, whichever occurs first.
- Conditions
- Soft-tissue Sarcoma
- Being tested
- Compound 451238
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound 451238Drug
Each patient will receive compound 451238 until disease progression unacceptable toxicities.
| Study group | Role | What they receive |
|---|---|---|
| Compound 451238 | Experimental | To assess the safety and tolerability of combining radiotherapy with compound 451238, treating advanced STS. Receives: Drug: Compound 451238 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Patients With Dose Limiting Toxicity
To assess the safety and tolerability of combining radiotherapy with compound 451238(avelumab) as evidenced by the rate of occurrence of dose limiting toxicities assessed using CTCAE v4.0.
.
Measured: Dose limiting toxicity was assessed from first dose of avelumab in week 1, then weekly until and including week 7 and every other week thereafter until and including the 7th dose of avelumab at week 13
Secondary outcomes (7)
Evaluate Local Control (LC)
Local control (LC) at 3 months from end of radiotherapy, calculated using Kaplan-Meier methods with patients without documented local progression censored at death or last known follow-up for surviving patients
Measured: 3 months from end of radiotherapy
Progression Free Survival (PFS)
Progression free survival (PFS) at 6 months and 1 year from start of avelumab, calculated using Kaplan-Meier methods
Measured: 1 Year
Overall Survival
Overall survival (OS) at 1 and 2 years from start of avelumab, calculated using Kaplan-Meier methods
Measured: Start of treatment to 2 years
Count of Patients by Worst Grade Acute Toxicity
Patients are assessed weekly from start of treatment up to and including week 11, for targeted toxicities (skin, myelitis, oesophagus, pneumonitis, cardiac) and any other organ toxicities, graded using the RTOG radiation toxicity grading system, which ranges from 0 (no symptoms) through 1(mild symptoms not requiring intervention), 2( moderate symptoms that may require intervention), 3(severe symptoms requiring more intensive intervention), 4 (life-threatening symptoms requiring urgent intervention), up to a maximum of 5 (death).
Measured: 11 weeks
Count of Patients by Worst Grade Late Toxicity
Patients are assessed every two weeks starting at 13 weeks from the start of treatment, for targeted radiotherapy toxicities (skin, myelitis, oesophagus, pneumonitis, cardiac) and any other organ toxicities, graded using the RTOG radiation toxicity grading system, which ranges from 0 (no symptoms) through 1(mild symptoms not requiring intervention), 2( moderate symptoms that may require intervention), 3(severe symptoms requiring more intensive intervention), 4 (life-threatening symptoms requiring urgent intervention), up to a maximum of 5 (death).
Measured: From 13 weeks from start of treatment until 90 days after the end of treatment
Pogression Free Survival (PFS) in PD-L1 Positive Population
Progression free survival (PFS) at 6 months and 1 year from start of avelumab, calculated using Kaplan-Meier methods in the PD-L1 positive subgroup
Measured: 1 year
Overall Survival (OS) in PD-L1 Positive Population
Overall survival (OS) at 6 months and 1 year from start of avelumab, calculated using Kaplan-Meier methods in the PD-L1 positive subgroup
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start5 Nov 2018
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Soft-tissue SarcomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Shane Zaidi, Principal investigator, MRCP FRCR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602833
- Sponsor's protocol ID
- CCR 4640
- Other IDs
- 2017-001316-11, 2017
- Status last verified
- Feb 2026
- First submitted
- 18 May 2018
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compound 451238 and Radiotherapy in Soft-tissue Sarcoma
- ClinicalTrials.gov ID
- NCT03602833
- Acronym / sponsor ID
- CCR 4640
- Conditions
- Soft-tissue Sarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Posted 2 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to assess the safety and tolerability of combining compound 451238 and radiotherapy, treating advanced STS.
Detailed description
Overall Study Design
This is a single centre open label, non-randomized, non-placebo phase 1 clinical trial to establish the safety and tolerability compound 451238 in combination with radiotherapy in patients with soft tissue sarcomas (STS). STS patients receiving radiotherapy to a tumour deposit above the diaphragm in the thorax, trunk or extremity, will receive radiotherapy. This study will recruit 12 patients and run as a fixed dose trial. Patients will continue on the treatment regimen unless they progress, suffer unacceptable toxicities, or withdraw from the trial.
Treatment Regimen
A maximum of 12 patients will be recruited. The safety and tolerabilty will be assessed in the first 3+3 patients with expansion to 12 patients as tolerated. All patients will be treated at the same fixed dose level of 10mg/kg, administered intravenously once every two weeks. A minimum gap of 2 weeks will be left between treatment of the first and second patient (with the combination of RT) to mitigate against multiple patients suffering acute toxicity. Patients will be followed for a minimum of 11 weeks from the initiation of radiotherapy with combined compound 451238 for the purposes of acute toxicity monitoring. Late toxicity monitoring will commence from 11 weeks + one day from initiation of radiotherapy with combined compound 451238 and continue until disease progression or initiation of new anti-cancer therapy.
Safety Follow-up - 30 Days
All patients will be required to attend a safety follow-up visit 30 days after the last dose of compound 451238 or before the initiation of a new anti-cancer treatment, whichever comes first.
Extended Safety Follow-up - 90 Days
Given the potential risk for delayed toxicities, an extended safety follow-up visit must be performed up to 90 days after the last dose of compound 451238 administration. The extended safety follow-up will be performed either via a site visit or via a telephone call with subsequent site visit requested in case any concerns noted during the telephone call. All AEs and SAEs that occur prior to the safety follow-up visit should be reported as described in the trial protocol. After the safety follow-up any unresolved AEs at the patient's last visit should be followed up for as long as medically indicated, but without further recording in the CRF.
Follow-up
Patients who discontinue trial treatment for any reason other than disease progression will move into the follow-up phase and will be assessed every 12 weeks by MRI or radiologic imaging to monitor disease status. Every effort will be made to collect information regarding disease status until the start of new anti-cancer therapy, disease progression, death, withdrawal or end of the study. Information regarding post-study anticancer treatment will be collected if new treatment is initiated.
Survival Follow-up
Once a patient experiences confirmed PD or starts a new anti-cancer therapy, the patient moves into the survival follow-up phase and will be followed up every 12 weeks to determine their disease status. This will be done by reviewing their medical notes and/or contacting the patient and/or General Practitioner directly. Patients will remain on this follow-up until death, withdrawal of consent, or the end of the study, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compound 451238 | Experimental | Drug: Compound 451238To assess the safety and tolerability of combining radiotherapy with compound 451238, treating advanced STS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have a diagnosis of soft tissue sarcoma with at least 2 metastases not suitable for cure using conventional treatments. At least one lesion must be suitable to receive palliative radiotherapy. The radiation tumour target volume must be between the neck and the diaphragm in the thorax, trunk of an extremity.
- Histological confirmed diagnosis of soft-tissue sarcoma .
- Age ≥ 18 years.
- Life expectancy of > 12 weeks.
- At least one site of accessible disease of pre- and post-treatment core biopsies.
Key exclusion criteria (27 listed)
- Systemic chemotherapy within 28 days prior to study entry.
- Prior systemic therapy.
- Patients who are curable by conventional multidisciplinary management.
- Patients with known central nervous system metastatic disease are ineligible for enrollment.
- 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.
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 |
|---|---|---|
| Compound 451238Each patient will receive compound 451238 until disease progression unacceptable toxicities. | Drug | Compound 451238 |
Primary outcome
Count of Patients With Dose Limiting Toxicity
Time frame: Dose limiting toxicity was assessed from first dose of avelumab in week 1, then weekly until and including week 7 and every other week thereafter until and including the 7th dose of avelumab at week 13
To assess the safety and tolerability of combining radiotherapy with compound 451238(avelumab) as evidenced by the rate of occurrence of dose limiting toxicities assessed using CTCAE v4.0. .
7 secondary outcomes
Evaluate Local Control (LC)
Time frame: 3 months from end of radiotherapy
Progression Free Survival (PFS)
Time frame: 1 Year
Overall Survival
Time frame: Start of treatment to 2 years
Count of Patients by Worst Grade Acute Toxicity
Time frame: 11 weeks
Count of Patients by Worst Grade Late Toxicity
Time frame: From 13 weeks from start of treatment until 90 days after the end of treatment
Pogression Free Survival (PFS) in PD-L1 Positive Population
Time frame: 1 year
Overall Survival (OS) in PD-L1 Positive Population
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Shane Zaidi principal investigator
MRCP FRCR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Compound 451238 in people with Soft-tissue Sarcoma, run by Royal Marsden NHS Foundation Trust 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 17 inclusion and 27 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: finished, as of the sponsor's last update on 2 Mar 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 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 2 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Count of Patients With Dose Limiting Toxicity (time frame: Dose limiting toxicity was assessed from first dose of avelumab in week 1, then weekly until and including week 7 and every other week thereafter until and including the 7th dose of avelumab at week 13). 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 2 Mar 2026.