Head and Neck CancerPhase 2EACHNCT03494322
EACH: Evaluating Avelumab in Combination With Cetuximab in Head and Neck Cancer
A Phase 2 study testing Avelumab and Cetuximab in people with Head and Neck Cancer and Squamous Cell Carcinoma, run by University College, London at 1 site in United Kingdom.
Trial summary
Head \& neck (H\&N) cancer is the eighth most common cancer in the UK. Advanced H\&N cancer which has come back after treatment or has spread to other parts of the body is incurable and the average life expectancy of these patients is less than a year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Squamous Cell Carcinoma
- What is being tested?
- Avelumab and Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2018to 23 Apr 2026
- 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
- Safety run in: Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma that is considered incurable by local therapies
- Phase II: Histologically/cytologically confirmed recurrent/metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies.
- Prior treatment with a platinum agent (either for recurrent/metastatic disease; or as part of radical intent multimodality treatment if disease has recurred within 6 months). (NB: This criterion is not applicable for the safety run-in).
- No previous treatment with cetuximab for metastatic/recurrent disease
- Age ≥18 years
- WHO Performance Status 0 or 1
Show all 16Show fewer
- Measurable disease according to RECIST v1.1
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
- Adequate venous access for administration of treatment and collection blood samples for exploratory biological samples
- Willing to have a new biopsy (NB: This criterion is not applicable for the safety run-in).
- Life expectancy of >3 months
- Women of child-bearing potential and male patients with partners of child-bearing potential must agree to use adequate contraception methods from date of informed consent, which must be continued for 120 days after completion of trial treatment.
- Able to give informed consent, indicating that the patient has been informed of and understands the experimental nature of the study, possible risks and benefits, trial procedures, and alternative options
- Willing and able to comply with the protocol for the duration of the study, including the treatment plan, investigations required and follow up visits.
Who cannot join
- Patients with undifferentiated nasopharyngeal or sino-nasal cancers.
- Disease suitable for treatment with curative intent.
- Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent.
- Treatment with any investigational agent within 4 weeks prior to the first dose of trial treatment.
- Anti-cancer monoclonal antibody therapy within 4 weeks prior to randomisation
- Chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to randomisation.
Show all 27Show fewer
- Persisting grade ≥2 toxicity related to prior therapy
- Patients with concurrent or previous malignancy that could compromise assessment of the primary or secondary endpoints of the trial.
- Women who are pregnant or breast feeding.
- Grade 3 or 4 peripheral neuropathy.
- Any serious and/or unstable pre-existing medical, psychiatric or other condition, 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.
- Patients who are not able to give informed consent for any reason.
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Hepatitis infection at screening
- Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
- Prior organ transplantation including allogenic stem-cell transplantation
- Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
- Active infection requiring systemic therapy
- Has received a live vaccine within 28 days prior to first dose of trial treatment
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (n.b. the use of physiologic doses of corticosteroids may be approved after consultation with UCL CTC)
- Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent.
- Current use of immunosuppressive medication
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organising pneumonia (i.e. bronchiolitis obliterans, cryptogenic organising pneumonia), or evidence of active pneumonitis on screening chest CT scan. (History of radiation pneumonitis in the radiation field is permitted).
- Significant cardiovascular disease
- Known prior severe hypersensitivity to either investigational product or any component in their formulations, including known severe hypersensitivity reactions to monoclonal antibodies
- Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis.
- Patients with a history of keratitis, ulcerative keratitis or severe dry eye.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EACH: A Randomised Phase II Study Evaluating the Safety and Anti-tumour Activity of the Combination of Avelumab and Cetuximab Relative to Avelumab Monotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Cancer
Head \& neck (H\&N) cancer is the eighth most common cancer in the UK. Advanced H\&N cancer which has come back after treatment or has spread to other parts of the body is incurable and the average life expectancy of these patients is less than a year. New drugs called immune checkpoint inhibitors work with the patient's own immune system to fight cancer. They are used in the clinic to treat a number of cancers, including H\&N cancer. It may be possible to make immune checkpoint inhibitors more effective by combining drugs that work in different ways. In effect, attacking the cancer from different angles. Cetuximab is a well-established drug that works by blocking signals that tell cancer cells to grow and divide into more cells. It also engages with the immune system within the tumour. The trial aims to see if giving cetuximab along with an immune checkpoint inhibitor drug called avelumab is better at treating advanced H\&N cancer than giving avelumab on its own.
These two drugs have not been given together before, so to start with, the investigator plans to enrol a small number of patients and give the patients avelumab + cetuximab to make sure the combination is safe at the doses chosen. After this, the investigator plans to enrol 114 patients with advanced H\&N cancer. Half the patients will be treated with avelumab alone and the other half with avelumab + cetuximab. Both drugs are given intravenously in the hospital once every 2 weeks.
Treatment lasts for up to a year and patients will be followed up for up to 2 years from the time they enter the study. Patients will be recruited from around 15 hospitals in the UK. Recruitment would be expected to start in the second quarter of 2018 and it will take about 29 months (Safety run-in: 5 months; Phase II: 24 months) to recruit all the patients.
Read the detailed description
This is a randomised phase II study comparing the efficacy of avelumab alone with avelumab + cetuximab combination in patients with platinum-resistant advanced or metastatic head \& neck cancer. The randomised phase II part of the trial will be preceded by a safety run-in.The objective of the safety run in is to make sure the combination of cetuximab and avelumab at the doses selected for the study are safe and tolerable.
In phase II, the main question the investigator wants to answer is whether or not giving avelumab and cetuximab together is better than giving avelumab alone to treat patients with head and neck cancer that have had previous treatment with cisplatin and whose cancer has come back or spread to other parts of the body. The investigator will compare the number of patients in each group whose cancer has not gotten any worse 6 months after joining the study.
The phase II part of the trial will recruit patients with head \& neck squamous cell carcinoma only. However, during the safety run-in, patients with other types of squamous cell carcinomas will also be eligible.
Target accrual:
Safety run-in: up to 16 patients with squamous cell carcinomas; Phase II: 114 patients with head \& neck squamous cell cancer
The safety run-in will recruit patients in cohorts of 3 at a time and all patients will be treated with the combination. The safety run in is a dose de-escalation design. That is, patients will be given the dose that is planed for use in phase II and if this proves not tolerable, the dose of cetuximab will be de-escalated and another cohort of patients will be recruited. The investigator will conclude the combination is safe and tolerable if less than 33% of patients who are treated experience side effects that lead to a dose reduction. The purpose is to ensure the safety of the combination prior to starting phase II, as these drugs have not been given together before. However, there is evidence from previous studies that these types of drugs can be combined safely. The trial aims to complete the safety run-in within 5 months and the phase II study within 24 months. The entire duration of recruitment is expected to be 29 months.
- Conditions
- Head and Neck Cancer, Squamous Cell Carcinoma
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Avelumab 10 mg/kg given IV
CetuximabDrug
Cetuximab 500* mg/m2 given IV
*Cetuximab dose will be dependent on outcome of safety run-in.
| Study group | Role | What they receive |
|---|---|---|
| Avelumab + cetuximab | Experimental | Patients will receive treatment in 4-week cycles and treatment may continue for up to 1 year.
Avelumab + cetuximab combination therapy:
Cycle 1
* Day 1: Cetuximab 500* mg/m2 given IV over approx 3 hrs
* Day 15: Cetuximab 500* mg/m2 given IV over approx 2 hrs + avelumab 10 mg/kg given IV over approx 1 hr
All other cycles:
- Days 1 and 15: Cetuximab 500* mg/m2 given IV over approx 2 hrs + avelumab 10 mg/kg given IV over approx 1 hr
*Cetuximab dose will be dependent on outcome of safety run-in.
There must be a 60 minute break between the administration of cetuximab and avelumab. Receives: Drug: Avelumab; Drug: Cetuximab |
| Avelumab monotherapy | Other | Patients will receive treatment in 4-week cycles and treatment may continue for up to 1 year.
Avelumab monotherapy will be given as follows:
All cycles Avelumab 10 mg/kg on days 1 and 15 given IV over approximately 1 hour Receives: Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety run-in: Occurrence of dose limiting toxicity
Detailed adverse event monitoring will be conducted according to CTCAE v4.03. Patients experiencing any of the following adverse events related to either cetuximab or avelumab during the DLT period will be considered to have experienced a DLT:
- Any grade 3 or 4 adverse reaction requiring a dose reduction of cetuximab
- Any adverse reaction resulting in a more than a 14 day treatment delay for any agent.
Measured: From start of cycle 1 (each cycle is 28 days) upto six weeks.
Phase II: Disease control rate at 24 weeks after randomisation
Assessed using iRECIST
Measured: From randomisation upto 24 weeks
Secondary outcomes (9)
Objective response (iCR or iPR) at 6 and 12 months
Using iRECIST
Measured: 6 months and 12 months after registration/randomisation
Disease control at 6 and 12 months
Using iRECIST
Measured: 6 and 12 months after registration/randomisation
Best overall response
Using iRECIST
Measured: From start of treatment to 24 months after registration, or upto start date of a new treatment for their disease, whichever came first, assessed up to 24 months.
Duration of response
Using iRECIST
Measured: From the date of the first response assessment showing iCR or iPR to the date of the response assessment documenting iPD according to iRECIST, assessed up to 24 months.
Overall survival
Measured: Time from registration/randomisation to death from any cause, assessed up to 24 months.
Time to Progression
Measured: From date of registration/randomisation to date of first documented progression, assessed up to 24 months.
Progression free survival
Measured: From date of registration/ randomisation to date of first documented progression, assessed up to 24 months.
Frequency and severity of adverse events
Measured: From informed consent to 90 days post last IMP treatment
Treatment related dose delays or treatment discontinuation
Measured: From start of treatment to end of treatment, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start20 Jul 2018
- Primary completion15 Sep 2021
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised phase II study with safety run in
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Martin Forster, FRCP PhD, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494322
- Sponsor's protocol ID
- UCL/17/0560
- Acronym
- EACH
- Status last verified
- May 2026
- First submitted
- 20 Mar 2018
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ng K, Metcalf R, Sacco J, Kong A, Wheeler G, Forsyth S, Bhat R, Ward J, Ensell L, Lowe H, Spanswick V, Hartley J, White L, Lloyd-Dehler E, Forster M. Protocol for the EACH trial: a multicentre phase II study evaluating the safety and antitumour activity of the combination of avelumab, an anti-PD-L1 agent, and cetuximab, as any line treatment for patients with recurrent/metastatic head and neck squamous cell cancer (HNSCC) in the UK. BMJ Open. 2023 Nov 27;13(11):e070391. doi: 10.1136/bmjopen-2022-070391.
PubMed 38011968
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EACH: A Randomised Phase II Study Evaluating the Safety and Anti-tumour Activity of the Combination of Avelumab and Cetuximab Relative to Avelumab Monotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT03494322
- Acronym / sponsor ID
- EACH / UCL/17/0560
- Conditions
- Head and Neck Cancer, Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 11 Apr 2018 (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.
Head \& neck (H\&N) cancer is the eighth most common cancer in the UK. Advanced H\&N cancer which has come back after treatment or has spread to other parts of the body is incurable and the average life expectancy of these patients is less than a year. New drugs called immune checkpoint inhibitors work with the patient's own immune system to fight cancer. They are used in the clinic to treat a number of cancers, including H\&N cancer. It may be possible to make immune checkpoint inhibitors more effective by combining drugs that work in different ways. In effect, attacking the cancer from different angles. Cetuximab is a well-established drug that works by blocking signals that tell cancer cells to grow and divide into more cells. It also engages with the immune system within the tumour. The trial aims to see if giving cetuximab along with an immune checkpoint inhibitor drug called avelumab is better at treating advanced H\&N cancer than giving avelumab on its own.
These two drugs have not been given together before, so to start with, the investigator plans to enrol a small number of patients and give the patients avelumab + cetuximab to make sure the combination is safe at the doses chosen. After this, the investigator plans to enrol 114 patients with advanced H\&N cancer. Half the patients will be treated with avelumab alone and the other half with avelumab + cetuximab. Both drugs are given intravenously in the hospital once every 2 weeks.
Treatment lasts for up to a year and patients will be followed up for up to 2 years from the time they enter the study. Patients will be recruited from around 15 hospitals in the UK. Recruitment would be expected to start in the second quarter of 2018 and it will take about 29 months (Safety run-in: 5 months; Phase II: 24 months) to recruit all the patients.
Detailed description
This is a randomised phase II study comparing the efficacy of avelumab alone with avelumab + cetuximab combination in patients with platinum-resistant advanced or metastatic head \& neck cancer. The randomised phase II part of the trial will be preceded by a safety run-in.The objective of the safety run in is to make sure the combination of cetuximab and avelumab at the doses selected for the study are safe and tolerable.
In phase II, the main question the investigator wants to answer is whether or not giving avelumab and cetuximab together is better than giving avelumab alone to treat patients with head and neck cancer that have had previous treatment with cisplatin and whose cancer has come back or spread to other parts of the body. The investigator will compare the number of patients in each group whose cancer has not gotten any worse 6 months after joining the study.
The phase II part of the trial will recruit patients with head \& neck squamous cell carcinoma only. However, during the safety run-in, patients with other types of squamous cell carcinomas will also be eligible.
Target accrual:
Safety run-in: up to 16 patients with squamous cell carcinomas; Phase II: 114 patients with head \& neck squamous cell cancer
The safety run-in will recruit patients in cohorts of 3 at a time and all patients will be treated with the combination. The safety run in is a dose de-escalation design. That is, patients will be given the dose that is planed for use in phase II and if this proves not tolerable, the dose of cetuximab will be de-escalated and another cohort of patients will be recruited. The investigator will conclude the combination is safe and tolerable if less than 33% of patients who are treated experience side effects that lead to a dose reduction. The purpose is to ensure the safety of the combination prior to starting phase II, as these drugs have not been given together before. However, there is evidence from previous studies that these types of drugs can be combined safely. The trial aims to complete the safety run-in within 5 months and the phase II study within 24 months. The entire duration of recruitment is expected to be 29 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised phase II study with safety run in
| Arm | Type | Receives |
|---|---|---|
| Avelumab + cetuximab | Experimental | Drug: Avelumab, Drug: CetuximabPatients will receive treatment in 4-week cycles and treatment may continue for up to 1 year. Avelumab + cetuximab combination therapy: Cycle 1 * Day 1: Cetuximab 500* mg/m2 given IV over approx 3 hrs * Day 15: Cetuximab 500* mg/m2 given IV over approx 2 hrs + avelumab 10 mg/kg given IV over approx 1 hr All other cycles: - Days 1 and 15: Cetuximab 500* mg/m2 given IV over approx 2 hrs + avelumab 10 mg/kg given IV over approx 1 hr *Cetuximab dose will be dependent on outcome of safety run-in. There must be a 60 minute break between the administration of cetuximab and avelumab. |
| Avelumab monotherapy | Other | Drug: AvelumabPatients will receive treatment in 4-week cycles and treatment may continue for up to 1 year. Avelumab monotherapy will be given as follows: All cycles Avelumab 10 mg/kg on days 1 and 15 given IV over approximately 1 hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Safety run in: Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma that is considered incurable by local therapies
- Phase II: Histologically/cytologically confirmed recurrent/metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies.
- Prior treatment with a platinum agent (either for recurrent/metastatic disease; or as part of radical intent multimodality treatment if disease has recurred within 6 months). (NB: This criterion is not applicable for the safety run-in).
- No previous treatment with cetuximab for metastatic/recurrent disease
- Age ≥18 years
Key exclusion criteria (27 listed)
- Patients with undifferentiated nasopharyngeal or sino-nasal cancers.
- Disease suitable for treatment with curative intent.
- Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent.
- Treatment with any investigational agent within 4 weeks prior to the first dose of trial treatment.
- Anti-cancer monoclonal antibody therapy within 4 weeks prior to randomisation
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 |
|---|---|---|
| AvelumabAvelumab 10 mg/kg given IV | Drug | Avelumab + cetuximab, Avelumab monotherapy |
| CetuximabCetuximab 500* mg/m2 given IV *Cetuximab dose will be dependent on outcome of safety run-in. | Drug | Avelumab + cetuximab |
Primary outcome
Safety run-in: Occurrence of dose limiting toxicity
Time frame: From start of cycle 1 (each cycle is 28 days) upto six weeks.
Detailed adverse event monitoring will be conducted according to CTCAE v4.03. Patients experiencing any of the following adverse events related to either cetuximab or avelumab during the DLT period will be considered to have experienced a DLT: * Any grade 3 or 4 adverse reaction requiring a dose reduction of cetuximab * Any adverse reaction resulting in a more than a 14 day treatment delay for any agent.
Phase II: Disease control rate at 24 weeks after randomisation
Time frame: From randomisation upto 24 weeks
Assessed using iRECIST
9 secondary outcomes
Objective response (iCR or iPR) at 6 and 12 months
Time frame: 6 months and 12 months after registration/randomisation
Disease control at 6 and 12 months
Time frame: 6 and 12 months after registration/randomisation
Best overall response
Time frame: From start of treatment to 24 months after registration, or upto start date of a new treatment for their disease, whichever came first, assessed up to 24 months.
Duration of response
Time frame: From the date of the first response assessment showing iCR or iPR to the date of the response assessment documenting iPD according to iRECIST, assessed up to 24 months.
Overall survival
Time frame: Time from registration/randomisation to death from any cause, assessed up to 24 months.
Time to Progression
Time frame: From date of registration/randomisation to date of first documented progression, assessed up to 24 months.
Progression free survival
Time frame: From date of registration/ randomisation to date of first documented progression, assessed up to 24 months.
Frequency and severity of adverse events
Time frame: From informed consent to 90 days post last IMP treatment
Treatment related dose delays or treatment discontinuation
Time frame: From start of treatment to end of treatment, assessed up to 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 38011968Ng K, Metcalf R, Sacco J, Kong A, Wheeler G, Forsyth S, Bhat R, Ward J, Ensell L, Lowe H, Spanswick V, Hartley J, White L, Lloyd-Dehler E, Forster M. Protocol for the EACH trial: a multicentre phase II study evaluating the safety and antitumour activity of the combination of avelumab, an anti-PD-L1 agent, and cetuximab, as any line treatment for patients with recurrent/metastatic head and neck squamous cell cancer (HNSCC) in the UK. BMJ Open. 2023 Nov 27;13(11):e070391. doi: 10.1136/bmjopen-2022-070391.
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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.
Martin Forster, FRCP PhD principal investigator
University College London Hospitals
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 and Cetuximab in people with Head and Neck Cancer and Squamous Cell Carcinoma, run by University College, London 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 16 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 20 May 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety run-in: Occurrence of dose limiting toxicity (time frame: From start of cycle 1 (each cycle is 28 days) upto six weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03494322, which also lists 1 linked publication.
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 20 May 2026.