Small Cell Lung CarcinomaPhase 1NCT02658214
Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors
A Phase 1 study testing paclitaxel + carboplatin, carboplatin + etoposide and gemcitabine + carboplatin in people with Small Cell Lung Carcinoma and Carcinoma, Squamous Cell of Head and Neck, run by AstraZeneca at 6 sites in 2 countries.
Trial summary
Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ cancer, PDAC, ESCC. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Small Cell Lung Carcinoma, Carcinoma, Squamous Cell of Head and Neck, Stomach Neoplasms
- What is being tested?
- paclitaxel + carboplatin, carboplatin + etoposide and gemcitabine + carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 28 Apr 2016to 14 Nov 2019
- Phase
- Phase 1
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years
- Written informed consent
- Patients with histologically or cytologically documented chemotherapy-naïve locally advanced unresectable or metastatic ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC, gastric cancer/GEJ, PDAC and ESCC.
- ECOG performance status of 0 or 1
- Patients must be considered suitable candidates for, and able to receive, first line chemotherapy for metastatic disease
- At least 1 lesion, not previously irradiated, that can be accurately measured at baseline
- No prior exposure to immune-mediated therapy
- Adequate organ and marrow function as defined below
Who cannot join
- Receipt of any investigational anticancer therapy within 28 days or 5 halflives, whichever is longer, prior to the first dose of study treatment
- Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment
- Any unresolved Grade ≥2 toxicity from previous anticancer therapy
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from study drugs, or compromise the ability of the patient to give written informed consent
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms 20. Active tuberculosis
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
South Korea4 sites
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 135-710
About this study
Official title: A Phase Ib Study to Evaluate the Safety and Tolerability of Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Patients With Advanced Solid Tumors.
Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ cancer, PDAC, ESCC.
Read the detailed description
7 cohorts of first-line chemotherapy regimens combined with durvalumab + tremelimumab.
This study will evaluate the safety and tolerability of durvalumab (MEDI4736) + tremelimumab in combination with first line chemotherapy regimens in patients with locally advanced or metastatic solid tumors: ovarian/peritoneal/fallopian tube cancer, squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC), small cell lung carcinoma (SCLC), and gastric/gastro-esophageal junction (GEJ) cancer, pancreatic ductal adenocarcinoma (PDAC) and esophageal squamous cell carcinoma (ESCC).
- Conditions
- Small Cell Lung Carcinoma, Carcinoma, Squamous Cell of Head and Neck, Stomach Neoplasms, Triple Negative Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms
- Being tested
- paclitaxel + carboplatin, carboplatin + etoposide, gemcitabine + carboplatin, nab-paclitaxel (paclitaxel-albumin) + carboplatin, oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)
- Keywords
- durvalumab, tremelimumab, metastatic, solid tumors, immuno-oncology, first-line chemotherapy, esophageal, pancreatic
- Medical subject headings
- Small Cell Lung Carcinoma, Squamous Cell Carcinoma of Head and Neck, Stomach Neoplasms, Triple Negative Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Pancreatic Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel + carboplatinDrug
Also called Platinum based Standard of Care Chemotherapy
IV infusion
carboplatin + etoposideDrug
Also called Platinum based Standard of Care Chemotherapy
IV infusion
gemcitabine + carboplatinDrug
Also called Platinum based Standard of Care Chemotherapy
IV infusion
nab-paclitaxel (paclitaxel-albumin) + carboplatinDrug
Also called Platinum based Standard of Care Chemotherapy
IV infusion
oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)Drug
Also called Platinum based Standard of Care Chemotherapy
IV infusion and bolus administration
durvalumabBiological
Also called MEDI4736
IV infusion
tremelimumabBiological
IV infusion
nab-paclitaxel (paclitaxel-albumin) + gemcitabineDrug
Also called Standard of Care Chemotherapy
IV infusion
cisplatin + 5-fluorouracil (5FU)Drug
Also called Platinum based Standard of Care Chemotherapy
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | ovarian/peritoneal/fallopian tube cancer and squamous cell carcinoma of the head and neck (SCCHN) Receives: Drug: paclitaxel + carboplatin; Biological: durvalumab; Biological: tremelimumab |
| Cohort 2 | Experimental | Small-cell lung cancer (SCLC) Receives: Drug: carboplatin + etoposide; Biological: durvalumab; Biological: tremelimumab |
| Cohort 3 | Experimental | Triple-negative breast cancer (TNBC) Receives: Drug: gemcitabine + carboplatin; Biological: durvalumab; Biological: tremelimumab |
| Cohort 4 | Experimental | Triple-negative breast cancer (TNBC) Receives: Drug: nab-paclitaxel (paclitaxel-albumin) + carboplatin; Biological: durvalumab; Biological: tremelimumab |
| Cohort 5 | Experimental | Gastric/gastro-esophageal junction (GEJ) Receives: Drug: oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid); Biological: durvalumab; Biological: tremelimumab |
| Cohort 6 | Experimental | Pancreatic ductal adenocarcinoma (PDAC) Receives: Biological: durvalumab; Biological: tremelimumab; Drug: nab-paclitaxel (paclitaxel-albumin) + gemcitabine |
| Cohort 7 | Experimental | Esophageal squamous cell carcinoma (ESCC) Receives: Biological: durvalumab; Biological: tremelimumab; Drug: cisplatin + 5-fluorouracil (5FU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory findings (including: clinical chemistry, hematology, and urinalysis)
To assess the safety and tolerability profile of first-line chemotherapy in combination with durvalumab + tremelimumab
Measured: Throughout the study, approximately three years
Incidence of Adverse Events
To assess incidence of Adverse Events for the safety and tolerability profile of first-line chemotherapy in combination with durvalumab and tremelimumab
Measured: Throughout the study, approximately three years
Tumor assessment based on RECIST 1.1 (for cohort 6 only)
To estimate the objective response rate (ORR) of durvalumab + tremelimumab + chemotherapy (for cohort 6 only)
Measured: Throughout the study, approximately three years (for cohort 6 only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study start28 Apr 2016
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
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 Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658214
- Sponsor's protocol ID
- D419SC00001
- Status last verified
- Aug 2020
- First submitted
- 11 Jan 2016
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lee DH, Kim HR, Keam B, Kato K, Kuboki Y, Gao H, Yovine A, Robbins SH, Ahn MJ. Safety and tolerability of first-line durvalumab with tremelimumab and chemotherapy in esophageal squamous cell carcinoma. Cancer Med. 2023 Aug;12(15):16066-16075. doi: 10.1002/cam4.6260. Epub 2023 Jul 25.
PubMed 37489066
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Evaluate the Safety and Tolerability of Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT02658214
- Acronym / sponsor ID
- D419SC00001
- Conditions
- Small Cell Lung Carcinoma, Carcinoma, Squamous Cell of Head and Neck, Stomach Neoplasms, Triple Negative Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms
- Keywords
- durvalumab, tremelimumab, metastatic, solid tumors, immuno-oncology, first-line chemotherapy, esophageal, pancreatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2016 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 18 Jan 2016 (estimated)
- 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.
Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ cancer, PDAC, ESCC.
Detailed description
7 cohorts of first-line chemotherapy regimens combined with durvalumab + tremelimumab.
This study will evaluate the safety and tolerability of durvalumab (MEDI4736) + tremelimumab in combination with first line chemotherapy regimens in patients with locally advanced or metastatic solid tumors: ovarian/peritoneal/fallopian tube cancer, squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC), small cell lung carcinoma (SCLC), and gastric/gastro-esophageal junction (GEJ) cancer, pancreatic ductal adenocarcinoma (PDAC) and esophageal squamous cell carcinoma (ESCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: paclitaxel + carboplatin, Biological: durvalumab, Biological: tremelimumabovarian/peritoneal/fallopian tube cancer and squamous cell carcinoma of the head and neck (SCCHN) |
| Cohort 2 | Experimental | Drug: carboplatin + etoposide, Biological: durvalumab, Biological: tremelimumabSmall-cell lung cancer (SCLC) |
| Cohort 3 | Experimental | Drug: gemcitabine + carboplatin, Biological: durvalumab, Biological: tremelimumabTriple-negative breast cancer (TNBC) |
| Cohort 4 | Experimental | Drug: nab-paclitaxel (paclitaxel-albumin) + carboplatin, Biological: durvalumab, Biological: tremelimumabTriple-negative breast cancer (TNBC) |
| Cohort 5 | Experimental | Drug: oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid), Biological: durvalumab, Biological: tremelimumabGastric/gastro-esophageal junction (GEJ) |
| Cohort 6 | Experimental | Biological: durvalumab, Biological: tremelimumab, Drug: nab-paclitaxel (paclitaxel-albumin) + gemcitabinePancreatic ductal adenocarcinoma (PDAC) |
| Cohort 7 | Experimental | Biological: durvalumab, Biological: tremelimumab, Drug: cisplatin + 5-fluorouracil (5FU)Esophageal squamous cell carcinoma (ESCC) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years
- Written informed consent
- Patients with histologically or cytologically documented chemotherapy-naïve locally advanced unresectable or metastatic ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC, gastric cancer/GEJ, PDAC and ESCC.
- ECOG performance status of 0 or 1
- Patients must be considered suitable candidates for, and able to receive, first line chemotherapy for metastatic disease
Key exclusion criteria (7 listed)
- Receipt of any investigational anticancer therapy within 28 days or 5 halflives, whichever is longer, prior to the first dose of study treatment
- Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment
- Any unresolved Grade ≥2 toxicity from previous anticancer therapy
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from study drugs, or compromise the ability of the patient to give written informed consent
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 |
|---|---|---|
| paclitaxel + carboplatinAlso: Platinum based Standard of Care ChemotherapyIV infusion | Drug | Cohort 1 |
| carboplatin + etoposideAlso: Platinum based Standard of Care ChemotherapyIV infusion | Drug | Cohort 2 |
| gemcitabine + carboplatinAlso: Platinum based Standard of Care ChemotherapyIV infusion | Drug | Cohort 3 |
| nab-paclitaxel (paclitaxel-albumin) + carboplatinAlso: Platinum based Standard of Care ChemotherapyIV infusion | Drug | Cohort 4 |
| oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)Also: Platinum based Standard of Care ChemotherapyIV infusion and bolus administration | Drug | Cohort 5 |
| durvalumabAlso: MEDI4736IV infusion | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
| tremelimumabIV infusion | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
| nab-paclitaxel (paclitaxel-albumin) + gemcitabineAlso: Standard of Care ChemotherapyIV infusion | Drug | Cohort 6 |
| cisplatin + 5-fluorouracil (5FU)Also: Platinum based Standard of Care ChemotherapyIV infusion | Drug | Cohort 7 |
Primary outcome
Laboratory findings (including: clinical chemistry, hematology, and urinalysis)
Time frame: Throughout the study, approximately three years
To assess the safety and tolerability profile of first-line chemotherapy in combination with durvalumab + tremelimumab
Incidence of Adverse Events
Time frame: Throughout the study, approximately three years
To assess incidence of Adverse Events for the safety and tolerability profile of first-line chemotherapy in combination with durvalumab and tremelimumab
Tumor assessment based on RECIST 1.1 (for cohort 6 only)
Time frame: Throughout the study, approximately three years (for cohort 6 only)
To estimate the objective response rate (ORR) of durvalumab + tremelimumab + chemotherapy (for cohort 6 only)
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 Aug 2020.
- Derived from this study: PubMed 37489066Lee DH, Kim HR, Keam B, Kato K, Kuboki Y, Gao H, Yovine A, Robbins SH, Ahn MJ. Safety and tolerability of first-line durvalumab with tremelimumab and chemotherapy in esophageal squamous cell carcinoma. Cancer Med. 2023 Aug;12(15):16066-16075. doi: 10.1002/cam4.6260. Epub 2023 Jul 25.
- Results of this clinical trial are available on www.astrazenecaclinicaltrials.comLink 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing paclitaxel + carboplatin, carboplatin + etoposide and gemcitabine + carboplatin in people with Small Cell Lung Carcinoma and Carcinoma, Squamous Cell of Head and Neck, run by AstraZeneca at 6 sites in 2 countries.
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 8 inclusion and 7 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 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Laboratory findings (including: clinical chemistry, hematology, and urinalysis) (time frame: Throughout the study, approximately three years). The study lists 3 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 NCT02658214, 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 Aug 2020.