Squamous Cell CarcinomaPhase 2NCT05535023
Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx Squamous Cell Carcinoma
A Phase 2 study testing SAR444245 and Cemiplimab in people with Squamous Cell Carcinoma and Oropharynx Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if SAR444245 given in combination with cemiplimab can help to kill cancer cells in patients with HPV-related oropharynx cancer who are scheduled to have surgery to remove the disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma, Oropharynx Cancer, Head and Neck Cancer
- What is being tested?
- SAR444245 and Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to 25 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent and in this protocol
- Age ≥ 18 years old
- Newly diagnosed HPV-related oropharynx squamous cell carcinoma, either confirmed or suspected. Patients with a primary oropharynx cancer consistent with squamous cell carcinoma based on clinical presentation and radiological features AND that are interested in participating in this study can have histological confirmation at the same time as the research biopsy. Patient can only participate in the study if squamous cell carcinoma histology AND HPV is confirmed.
- Disease stage I per the TNM AJCC 8th Edition
- Patients must be amenable to TORS in the opinion of the treating head and neck surgeon
- Patients must be willing to undergo baseline biopsy to obtain tumor material
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- Disease must be measurable by RECIST 1.1
- Performance status ECOG 0 or 1
- Baseline pulse oximetry > 92%
- Patients must have adequate normal organ and marrow function. Abnormal organ and marrow function is defined as:
- neutrophils <1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL, total bilirubin >1.5 upper limit of normal (ULN) (except known Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5 of upper limit of normality (ULN) Glomerular Filtration Rate (GFR) <40 mL/min/1.73 m2 (GFR will be calculated using the CKD-EPI equation per institutional standard)
- Female patients with reproductive potential must practice two effective contraceptive measures for the duration of study drug therapy and for at least 120 days after completion of study therapy. The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom, copper intrauterine device, sponge,
- or spermicide. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).
- Male participants with female partners of childbearing potential are eligible to participate if they agree to either be abstinent from penile-vaginal intercourse or use a male condom plus partner use of a hormonal contraceptive method during the treatment period and for at least 120 days after the last dose of study treatment. Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration.
- Patient weight must be at least 50 Kg
Who cannot join
- History of previous malignancy other than malignancy treated with curative intent and with no evidence of active disease ≥3 years before the first dose of the study drugs and of low potential risk for recurrence. Patients with the following diagnoses represents an exception and may enroll:
- Non-melanoma skin cancers with no current evidence of disease
- Melanoma in situ with no current evidence of disease
- Localized cancer of the prostate with prostate-specific antigen of <1 ng/mL
- Treated or localized well-differentiated thyroid cancer
- Treated cervical carcinoma in situ
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- Treated ductal/lobular carcinoma in situ of the breast
- International Normalized Ratio (INR) or Prothrombin Time (PT) or Activated Partial Thromboplastin Time (aPTT) >1.5 × ULN unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
- Participants under anti-hypertensive treatment who cannot temporarily (for at least 36 hours) withhold antihypertensive medications prior to each IMP dosing.
- Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤14 days prior to administration of investigational product. Patients with known hepatitis B, hepatitis C (HCV), or HIV infection could go on study provided the viral load is undetectable at Screening.
- Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary function or uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the patient associated with his or her participation in the study.
- Female subjects who are pregnant or breast-feeding
- Known hypersensitivity (≥ Grade 3) to or contraindication for the use of any study intervention or components thereof, including premedication to be administered in this study, as well as PEG or any pegylated drug and E. coli-derived protein".
- Patient with active, known, or suspected autoimmune disease that has required systemic therapy. Exceptions: patients with vitiligo, type I diabetes mellitus, and endocrinopathies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx
To learn if SAR444245 given in combination with cemiplimab can help to kill cancer cells in patients with HPV-related oropharynx cancer who are scheduled to have surgery to remove the disease
Read the detailed description
Primary Objective(s):
- To evaluate the major pathologic response (MPR; ≤ 10% residual tumor) rate of SAR444245 combined with cemiplimab administered in the neoadjuvant setting
Secondary Objective(s):
- To evaluate the safety and tolerability of neoadjuvant SAR444245 plus cemiplimab using NCI-CTCAE version 5.0
- To evaluate the feasibility of neoadjuvant SAR444245 plus cemiplimab by assessing the percentage of patients not able to undergo the initially proposed surgery due to disease progression or an adverse event attributed to the drug combination
- To evaluate the objective response rate (ORR) to neoadjuvant SAR444245 plus cemiplimab by RECIST 1.1 (12)
- To evaluate the proportion of patients who changed TNM stage (ie: change of TNM stage post-treatment as compared to pre-treatment) followed neoadjuvant SAR444245 plus cemiplimab
- To assess the 1-year disease-free (DFS) survival rate
Exploratory Objective(s):
- To evaluate HPV cell-free DNA as a biomarker of response to therapy
- To evaluate pre- and post- treatment tumor and blood biomarkers and correlate with pathologic and clinical response and toxicity.
- To evaluate the relationship between matched time-point RECIST criteria on anatomic imaging (T1/T2 MRI or contrast CT) with candidate functional imaging (diffusion-weighted imaging, MR relaxometry, MRI/CT radiomics), pathologic (MPR) and serum (cfDNA) novel biomarkers of therapeutic response.
- Being tested
- SAR444245, Cemiplimab
- Medical subject headings
- Carcinoma, Squamous Cell, Oropharyngeal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR444245Drug
Given by vein (IV)
CemiplimabDrug
Given by vein (IV)
| Study group | Role | What they receive |
|---|---|---|
| SAR444245 plus Cemiplimab | Experimental | Participants will receive SAR444245 and Cemiplimab by vein on Day 1 of Cycles 1 and 2. Each drug's infusion should take about 30 minutes. Receives: Drug: SAR444245; Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
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 posted10 Sep 2022
- Study start24 Aug 2022
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Why it stopped: PI Request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Renata Ferrarotto, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535023
- Sponsor's protocol ID
- 2022-0013
- Other IDs
- NCI-2022-07560
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx
- ClinicalTrials.gov ID
- NCT05535023
- Acronym / sponsor ID
- 2022-0013
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI Request
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 10 Sep 2022 (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 learn if SAR444245 given in combination with cemiplimab can help to kill cancer cells in patients with HPV-related oropharynx cancer who are scheduled to have surgery to remove the disease
Detailed description
Primary Objective(s):
- To evaluate the major pathologic response (MPR; ≤ 10% residual tumor) rate of SAR444245 combined with cemiplimab administered in the neoadjuvant setting
Secondary Objective(s):
- To evaluate the safety and tolerability of neoadjuvant SAR444245 plus cemiplimab using NCI-CTCAE version 5.0
- To evaluate the feasibility of neoadjuvant SAR444245 plus cemiplimab by assessing the percentage of patients not able to undergo the initially proposed surgery due to disease progression or an adverse event attributed to the drug combination
- To evaluate the objective response rate (ORR) to neoadjuvant SAR444245 plus cemiplimab by RECIST 1.1 (12)
- To evaluate the proportion of patients who changed TNM stage (ie: change of TNM stage post-treatment as compared to pre-treatment) followed neoadjuvant SAR444245 plus cemiplimab
- To assess the 1-year disease-free (DFS) survival rate
Exploratory Objective(s):
- To evaluate HPV cell-free DNA as a biomarker of response to therapy
- To evaluate pre- and post- treatment tumor and blood biomarkers and correlate with pathologic and clinical response and toxicity.
- To evaluate the relationship between matched time-point RECIST criteria on anatomic imaging (T1/T2 MRI or contrast CT) with candidate functional imaging (diffusion-weighted imaging, MR relaxometry, MRI/CT radiomics), pathologic (MPR) and serum (cfDNA) novel biomarkers of therapeutic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAR444245 plus Cemiplimab | Experimental | Drug: SAR444245, Drug: CemiplimabParticipants will receive SAR444245 and Cemiplimab by vein on Day 1 of Cycles 1 and 2. Each drug's infusion should take about 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent and in this protocol
- Age ≥ 18 years old
- Newly diagnosed HPV-related oropharynx squamous cell carcinoma, either confirmed or suspected. Patients with a primary oropharynx cancer consistent with squamous cell carcinoma based on clinical presentation and radiological features AND that are interested in participating in this study can have histological confirmation at the same time as the research biopsy. Patient can only participate in the study if squamous cell carcinoma histology AND HPV is confirmed.
- Disease stage I per the TNM AJCC 8th Edition
- Patients must be amenable to TORS in the opinion of the treating head and neck surgeon
Key exclusion criteria (14 listed)
- History of previous malignancy other than malignancy treated with curative intent and with no evidence of active disease ≥3 years before the first dose of the study drugs and of low potential risk for recurrence. Patients with the following diagnoses represents an exception and may enroll:
- International Normalized Ratio (INR) or Prothrombin Time (PT) or Activated Partial Thromboplastin Time (aPTT) >1.5 × ULN unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
- Participants under anti-hypertensive treatment who cannot temporarily (for at least 36 hours) withhold antihypertensive medications prior to each IMP dosing.
- Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤14 days prior to administration of investigational product. Patients with known hepatitis B, hepatitis C (HCV), or HIV infection could go on study provided the viral load is undetectable at Screening.
- Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary function or uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the patient associated with his or her participation in the study.
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 |
|---|---|---|
| SAR444245Given by vein (IV) | Drug | SAR444245 plus Cemiplimab |
| CemiplimabGiven by vein (IV) | Drug | SAR444245 plus Cemiplimab |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: through study completion an average of 1 year.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- M D 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. This study is not recruiting at the moment.
Renata Ferrarotto, 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 2 study testing SAR444245 and Cemiplimab in people with Squamous Cell Carcinoma and Oropharynx Cancer, 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 15 inclusion and 14 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: withdrawn, as of the sponsor's last update on 13 Sep 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 (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 13 Sep 2023.