Recurrent Epithelial Cancer of OvaryPhase 2NCT03312114
Anti-PD-L1 and SAbR for Ovarian Cancer
A Phase 2 study testing Avelumab in people with Recurrent Epithelial Cancer of Ovary and Primary Peritoneal Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Programmed death-1 receptor ligand (PD-L1) the ligand for PD-1 is a key therapeutic target in the reactivation of the immune response against multiple cancers. Pharmacologic inhibitors of PD-1 have also demonstrated significant anti-tumor activity and are currently under active clinical exploration. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Epithelial Cancer of Ovary, Primary Peritoneal Carcinoma, Fallopian Tube Cancer
- What is being tested?
- Avelumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2017to 19 Mar 2019
- Phase
- Phase 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects aged ≥ 18 years.
- Performance ECOG status of 0-2
- Patient is able and willing to comply with protocol and study procedures for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up visits.
- Adequate Physiologic function:
- Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused)
- Hepatic: Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).
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- Renal: Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
- Pregnancy and contraception:
- Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential.
- Contraception: Women of child-bearing potential and their male partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry.,
- Histologic diagnosis of recurrent epithelial ovarian ,fallopian ,peritoneal cancer
- Patients with platinum sensitive ovarian cancer must have progressed through at least one platinum containing regimen for recurrent disease.
- Patients with platinum resistant ovarian cancer must have progressed through at least one prior chemotherapy regimen for recurrent ovarian cancer.
- Patients must have received at least one prior chemotherapy regimen and up to any number of prior systemic regimens including chemotherapy and molecular targeted therapy other than PD1/ PDL1/ PDL2 inhibitors.
- Metastatic disease of at least two Non-CNS sites (including the index lesion to be treated) measurable by RECIST criteria with at least one site outside of the radiation field and evaluable by RECIST criteria for evaluation of response.
- Ability to understand and the willingness to sign a written informed consent -
Who cannot join
- IMMUNOSUPRESSANTS: "Current use of immunosuppressive medication, EXCEPT for the following: a. Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)."
- AUTOIMMUNE DISEASE: "Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible."
- ORGAN TRANSPLANTATION: "Prior organ transplantation including allogenic stem-cell transplantation."
- HIV/AIDS: "Known history of testing positive for HIV or known acquired immunodeficiency syndrome."
- HEPATITIS: "Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)"
- VACCINATION: "Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines "
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- HYPERSENSITIIVTY TO STUDY DRUG: "Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3)"
- CARDIOVASCULAR 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."
- OTHER PERSISTING TOXICITIES: "Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 2); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable."
- Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis ,Severe COPD requiring > 3 hospitalization in the past year Or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- No concomitant therapy with any of the following: IL2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; or other investigational therapies; all such therapies must have been discontinued >4weeks prior to registration.
- No active TB,
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must not be pregnant or nursing.
- No history of prior treatment with inhibitor of PD-1 or PD-L1 or PDL2.
- Major surgery within 2 weeks prior to registration or first dose of drug
- Subjects who have had radiation therapy within 2 weeks prior to first dose of drug
- Uncontrolled adrenal insufficiency or active chronic liver disease
- Any history of CNS metastases that is not adequately treated (surgery or radiation ) >14 days prior to registration.
- Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalent are permitted (although not encouraged) in the absence of active autoimmune disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Phase II Trial of Concurrent Anti-PD-L1 and SAbR for Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer (With Safety lead-in)
Programmed death-1 receptor ligand (PD-L1) the ligand for PD-1 is a key therapeutic target in the reactivation of the immune response against multiple cancers. Pharmacologic inhibitors of PD-1 have also demonstrated significant anti-tumor activity and are currently under active clinical exploration. avelumab (MSB0010718C; anti-PD-L1 is a fully human anti-PD-L1 igG1 antibody that has shown promising efficacy and an acceptable safety profile in multiple tumor types.
Radiation therapy (RT) is one of the mainstream treatments of cancer therapy along with surgery and chemotherapy, yet RT is the only treatment that does not leave the patients immunocompromised (unlike chemotherapy) and keeps the dying tumor / antigen depot within the host (unlike surgery), providing an opportunity for antigen presentation. Therefore, RT is a rational choice to combine with immunotherapy for cancer treatment.
Read the detailed description
Screening/Baseline Procedures Assessments performed exclusively to determine eligibility for this study will be done only after obtaining informed consent. Assessments performed for clinical indications (not exclusively to determine study eligibility) may be used for baseline values even if the studies were done before informed consent was obtained.
All screening procedures must be performed within 28 days prior to registration unless otherwise stated. The screening procedures include:
- Informed Consent
- Medical history: Complete medical and surgical history, history of infections
- Demographics: Age, gender, race, ethnicity
- Review subject eligibility criteria
- Review previous and concomitant medications
- Physical exam including vital signs, height and weight: Vital signs (temperature, pulse, respirations, blood pressure), height, weight
- Performance status: Performance status evaluated prior to study entry according to Appendix #/letter.
- Adverse event assessment: Baseline adverse events will be assessed. See section 6 for Adverse Event monitoring and reporting.
- Hematology CBC and diff ( within 2 weeks of registration)
- T 4 levels, TSH and CMP as below: Comprehensive metabolic panel (CMP) to include: albumin, alkaline phosphatase, ALT/SGPT, AST/SGOT, BUN, creatinine, electrolytes (sodium, potassium, calcium, chloride, bicarbonate), glucose, and total bilirubin. (within 2 weeks of registration)- Pregnancy test (for females of child bearing potential)( within 2 weeks of registration)
- Tumor assessment:Baseline imaging by CT scan of chest , abdomen, and pelvis.
Procedures During Treatment
- Prior to Each Treatment Cycle
- Physical exam, vital signs
- Hematology
- Serum chemistries
- Every 8 weeks after start till end of treatment Serum TSH, pregnancy test and CT chest abdomen and pelvis 30 days after treatment termination
- Physical exam, vital signs
- Hematology
- Serum chemistries
- additional Immune co-relate lab testing: Prior to cycle 1, cycle 3, cycle 5, cycle 7 and 2 weeks post last cycle.
Follow-up Procedures
- For patients who are still receiving Avelumab: Subject will be followed every eight weeks (+/- 2 weeks) starting from the beginning of treatment for the first year, then every 12 weeks (+/- 2 weeks) till 2 years after last dose of drug The following procedures will be performed at each follow up:
- Physical exam, PS, vital signs, medication review, AE assessment
- Blood collection per time table and for labs
- Radiographic imaging: Tumor assessments will be completed by the investigator using the RECIST criteria as above.
- CT chest, abdomen and pelvis with IV contrast, if allowable by renal function
- After that, survival information will be collected every 6 months until patient death.
- For patients who have been discontinued from Avelumab : Subject will be followed 30 days from last dose (±7 days, or may be on date of discontinuation ±7 days if the date of discontinuation is more than 37 days after last dose) and then 3-4 months from last dose.
The following procedures will be performed at the first two visits:
- Physical exam, PS, vital signs, medication review, AE assessment
- Subsequent anti-cancer treatment/s
- For first visit only, or may repeat if study drug related toxicity persists: CBC w/ differential, LFTs, BUN, creatinine, fasting glucose, and TSH
After that, survival information will be collected every 6 months until patient death.
- Being tested
- Avelumab
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Also called Bavencio
Avelumab* (MSB0010718C; anti-PD-L1 is a fully human anti-PD- L1 IgG1 antibody)
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Avelumab and SABR Receives: Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess Overall Clinical Response Rates Per RECIST Criteria.
Analysis of (with safety lead-in) trial of combined Avelumab (MSB0010718C) anti-PD-L1checkpoint blockade with SAbR for Recurrent Ovarian and peritoneal ,fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria .
Measured: 1 year,4 months
Secondary outcomes (1)
Overall Survival
Patients were started on alternative therapy and were not followed after starting alternative therapy.
Study was stopped because drug was found to be ineffective by the pharmaceutical company
Measured: 1 year, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start9 Nov 2017
- Primary completion19 Mar 2019
- Study completion19 Mar 2019
Why it stopped: low accrual
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 Recurrent Epithelial Cancer of OvaryStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Kevin Albuquerque, MD, Principal investigator, kevin.albuquerque@utsouthwestern.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312114
- Sponsor's protocol ID
- STU 032017-078
- Status last verified
- Oct 2020
- First submitted
- 14 Sep 2017
- Last updated
- 12 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Concurrent Anti-PD-L1 and SAbR for Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer (With Safety lead-in)
- ClinicalTrials.gov ID
- NCT03312114
- Acronym / sponsor ID
- STU 032017-078
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Posted 12 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Programmed death-1 receptor ligand (PD-L1) the ligand for PD-1 is a key therapeutic target in the reactivation of the immune response against multiple cancers. Pharmacologic inhibitors of PD-1 have also demonstrated significant anti-tumor activity and are currently under active clinical exploration. avelumab (MSB0010718C; anti-PD-L1 is a fully human anti-PD-L1 igG1 antibody that has shown promising efficacy and an acceptable safety profile in multiple tumor types.
Radiation therapy (RT) is one of the mainstream treatments of cancer therapy along with surgery and chemotherapy, yet RT is the only treatment that does not leave the patients immunocompromised (unlike chemotherapy) and keeps the dying tumor / antigen depot within the host (unlike surgery), providing an opportunity for antigen presentation. Therefore, RT is a rational choice to combine with immunotherapy for cancer treatment.
Detailed description
Screening/Baseline Procedures Assessments performed exclusively to determine eligibility for this study will be done only after obtaining informed consent. Assessments performed for clinical indications (not exclusively to determine study eligibility) may be used for baseline values even if the studies were done before informed consent was obtained.
All screening procedures must be performed within 28 days prior to registration unless otherwise stated. The screening procedures include:
- Informed Consent
- Medical history: Complete medical and surgical history, history of infections
- Demographics: Age, gender, race, ethnicity
- Review subject eligibility criteria
- Review previous and concomitant medications
- Physical exam including vital signs, height and weight: Vital signs (temperature, pulse, respirations, blood pressure), height, weight
- Performance status: Performance status evaluated prior to study entry according to Appendix #/letter.
- Adverse event assessment: Baseline adverse events will be assessed. See section 6 for Adverse Event monitoring and reporting.
- Hematology CBC and diff ( within 2 weeks of registration)
- T 4 levels, TSH and CMP as below: Comprehensive metabolic panel (CMP) to include: albumin, alkaline phosphatase, ALT/SGPT, AST/SGOT, BUN, creatinine, electrolytes (sodium, potassium, calcium, chloride, bicarbonate), glucose, and total bilirubin. (within 2 weeks of registration)- Pregnancy test (for females of child bearing potential)( within 2 weeks of registration)
- Tumor assessment:Baseline imaging by CT scan of chest , abdomen, and pelvis.
Procedures During Treatment
- Prior to Each Treatment Cycle
- Physical exam, vital signs
- Hematology
- Serum chemistries
- Every 8 weeks after start till end of treatment Serum TSH, pregnancy test and CT chest abdomen and pelvis 30 days after treatment termination
- Physical exam, vital signs
- Hematology
- Serum chemistries
- additional Immune co-relate lab testing: Prior to cycle 1, cycle 3, cycle 5, cycle 7 and 2 weeks post last cycle.
Follow-up Procedures
- For patients who are still receiving Avelumab: Subject will be followed every eight weeks (+/- 2 weeks) starting from the beginning of treatment for the first year, then every 12 weeks (+/- 2 weeks) till 2 years after last dose of drug The following procedures will be performed at each follow up:
- Physical exam, PS, vital signs, medication review, AE assessment
- Blood collection per time table and for labs
- Radiographic imaging: Tumor assessments will be completed by the investigator using the RECIST criteria as above.
- CT chest, abdomen and pelvis with IV contrast, if allowable by renal function
- After that, survival information will be collected every 6 months until patient death.
- For patients who have been discontinued from Avelumab : Subject will be followed 30 days from last dose (±7 days, or may be on date of discontinuation ±7 days if the date of discontinuation is more than 37 days after last dose) and then 3-4 months from last dose.
The following procedures will be performed at the first two visits:
- Physical exam, PS, vital signs, medication review, AE assessment
- Subsequent anti-cancer treatment/s
- For first visit only, or may repeat if study drug related toxicity persists: CBC w/ differential, LFTs, BUN, creatinine, fasting glucose, and TSH
After that, survival information will be collected every 6 months until patient death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: AvelumabAvelumab and SABR |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female subjects aged ≥ 18 years.
- Performance ECOG status of 0-2
- Patient is able and willing to comply with protocol and study procedures for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up visits.
- Adequate Physiologic function:
- Pregnancy and contraception:
Key exclusion criteria (21 listed)
- IMMUNOSUPRESSANTS: "Current use of immunosuppressive medication, EXCEPT for the following: a. Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)."
- AUTOIMMUNE DISEASE: "Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible."
- ORGAN TRANSPLANTATION: "Prior organ transplantation including allogenic stem-cell transplantation."
- HIV/AIDS: "Known history of testing positive for HIV or known acquired immunodeficiency syndrome."
- HEPATITIS: "Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)"
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 |
|---|---|---|
| AvelumabAlso: BavencioAvelumab* (MSB0010718C; anti-PD-L1 is a fully human anti-PD- L1 IgG1 antibody) | Drug | Single arm |
Primary outcome
To Assess Overall Clinical Response Rates Per RECIST Criteria.
Time frame: 1 year,4 months
Analysis of (with safety lead-in) trial of combined Avelumab (MSB0010718C) anti-PD-L1checkpoint blockade with SAbR for Recurrent Ovarian and peritoneal ,fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria .
1 secondary outcome
Overall Survival
Time frame: 1 year, 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Kevin Albuquerque, MD principal investigator
kevin.albuquerque@utsouthwestern.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avelumab in people with Recurrent Epithelial Cancer of Ovary and Primary Peritoneal Carcinoma, run by University of Texas Southwestern Medical 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 16 inclusion and 21 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: stopped early, as of the sponsor's last update on 12 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 12 Nov 2020). 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?
To Assess Overall Clinical Response Rates Per RECIST Criteria. (time frame: 1 year,4 months). 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 12 Nov 2020.