ImmunotherapyPhase 2GUIDE2REPAIRNCT04169841
Study Evaluating the Efficacy of a Double Immunotherapy Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes After Olaparib Treatment
A Phase 2 study testing olaparib, durvalumab, tremelimumab in people with Immunotherapy, run by Centre Georges Francois Leclerc at 8 sites in France.
Trial summary
The study propose to generate a clinical trial based on precision medicine to evaluate the use of immunotherapy in patients with altered homologous recombination repair genes and without progression after prior targeted therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunotherapy
- What is being tested?
- olaparib, durvalumab, tremelimumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 8 sitesFrance
- Study dates
- 10 Feb 2020to 10 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Exome sequencing of tumor and constitutive DNA should have been already performed
- Patients must be diagnosed with a solid malignancy with the following cancer histologically confirmed with specified inclusion for each cohort:
- Metastatic breast cancer:
- In second line
- third line and after
Show all 34Show fewer
- Metastatic lung cancer:
- Non-small cell lung cancer
- Must have progressed after at least a first line with platinum based therapy
- Metastatic head and Neck cancer
- Must have progressed after at least a first line with platinum based therapy
- Metastatic endometrial cancer • Progression after 1 prior systemic, platinum-based chemotherapy regimen for EC. Participants may have received up to 1 additional line of platinum-based chemotherapy if given in the neoadjuvant or adjuvant treatment setting. There is no restriction regarding prior hormonal therapy
- Metastatic clear cell renal cancer
- Must have progressed after at least a line with anti-angiogenic agent. Metastatic pancreatic cancer
- Must have progressed after at least a line with FOLFIRINOX regimen and/or Gemcitabin based chemotherapy
- Locally advanced or metastatic ovarian cancer
- Must have received at least one and no more than two lines of prior platinum-containing therapy and progressed after the most recent platinum therapy in a platinum-sensitive timeframe (more than 6 months from the last dose of platinum before randomization)
- Metastatic urothelial cancer • From the second line and regardless previous treatment (except immunotherapy)
- Metastatic prostate cancer
- Documented evidence of metastatic castration resistant prostate cancer (mCRPC)
- Ongoing therapy with LHRH analog or bilateral orchiectomy
- Must have progressed on prior new hormonal agent (enzalutamine or abiraterone) and taxane chemotherapy
- Presence of mutation in homologous repair gene
- Age >18 years
- Performance status ECOG of 0 or 1.
- Life expectancy ≥ 6 months.
- At least one lesion measurable as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1)
- Body weight >30 kg.
- 10. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential
- Male patients must use a condom during treatment of STEP1 (olaparib) and STEP2 (durvalumab and tremelimumab) and for 180 days after the last dose when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential
- Patient is willing and able to comply with the protocol for the duration of the study.
- For all oral medications patients must be able to comfortably swallow capsules;
- 16. CT Scan evaluation after 6 weeks of olaparib should present response or stable disease as defined by RECIST v1.1 criteria.
Who cannot join
- Involvement in the planning and/or conduct of the study
- Patient with mBRCA1 / 2 that are eligible for current marketing authorization for olaparib (ovarian cancer),and patient eligible for AstraZeneca registration clinical trials, particularly for the prostate cohort
- Specific exclusion criteria each cohort:
- Metastatic breast cancer:
- Only for patient second line : patient with mBRCA1 / 2 that are eligible for current marketing authorization for Olaparib (ovarian cancer) and patient eligible for AstraZeneca registration clinical trials).
- Metastatic lung cancer
Show all 41Show fewer
- Small cell cancer
- oncogenic addiction : EGFR mutation or BRAF mutation or ALK rearrangement or ROS1 mutation Locally advanced or metastatic ovarian cancer
- Patient with mBRCA1 / 2 that are eligible for current marketing authorization for Olaparib (ovarian cancer) and patient eligible for AstraZeneca registration clinical trials.
- Metastatic prostate cancer
- Untreated or first line patients
- Metastatic head and Neck cancer, Metastatic endometrial cancer, Metastatic clear cell renal cancer, Metastatic pancreatic cancer \& Metastatic urothelial cancer:
- None
- Participation in another clinical study with an investigational product during within 2 months of first administration of Olaparib.
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Receipt of the last dose of anticancer therapy ≤21 days prior to the first dose of olaparib or 5 times its half-life, whichever is less.
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, ototoxicity, vitiligo, and the laboratory values defined in the inclusion criteria
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug. Radiotherapy (non-palliative) within 21 days prior the first dose of study drug or within 6 weeks for therapeutic doses of MIBG or craniospinal irradiation. Palliative RT (which would be <30% of the bone marrow) to non-target lesions is allowed.
- Major surgical procedure within 28 days prior to the first dose of olaparib and patients must have recovered from any effects of any major surgery.
- Patients unable to swallow orally administered medication and patients with Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs
- History of allogenic organ, bone marrow or double umbilical cord blood transplantation.
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness or patient considered a poor medical risk due to a serious, uncontrolled medical disorder, including but not limited to, ongoing or active infection, symptomatic congestive heart failure
- Currently taking medications with known risk of prolonging the QT interval or inducing Torsades de Pointes.
- Concomitant use of known strong or moderate CYP3A inducers.
- Resting ECG indicating uncontrolled, potentially reversible cardiac conditions or patients with congenital long QT syndrome
- Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
- History of another primary malignancy
- History of leptomeningeal carcinomatosis
- Patient with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease.
- History of active primary immunodeficiency
- Immunocompromised patients
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. Patients with a past or resolved HBV infection are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential
- Prior treatment with any PARP inhibitor including olaparib or immunotherapy.
- Concomitant use of known strong or moderate cytochrome CYP3A inhibitors and concomitant use of known strong or moderate CYP3A inducers.
- Patients should not enter the study if any of the exclusion criteria from STEP 1 and the following criteria for STEP 2 are fulfilled:
- Patient with progression observed on CT scan performed after 6 weeks of olaparib (STEP 1).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU Amiens
Amiens
CHRU Jean Minjoz
Besançon
Institut Bergonié
Bordeaux
Centre Georges François Leclerc
Dijon, 21000
CHU François Mitterrand
Dijon
Institut Hospitalier Franco-Britannique
Levallois-Perret
Centre Oscar Lambret
Lille
Centre Leon Berard
Lyon
About this study
Official title: Precision Medicine Phase II Study Evaluating the Efficacy of a Double Immunotherapy by Durvalumab and Tremelimumab Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes Mutation in Response or Stable After Olaparib Treatment
The study propose to generate a clinical trial based on precision medicine to evaluate the use of immunotherapy in patients with altered homologous recombination repair genes and without progression after prior targeted therapy.
Read the detailed description
With the development of cost effective and rapid technology of genome sequencing, precision medicine becomes a new way to think oncology. Current targets involve mainly tyrosine kinase, but DNA repair machinery could also be targetable. Some of DNA repair aberrations have been associated with sensitivity to platinum and poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors like Olaparib, suggesting that treatment with a PARP inhibitor may exploit a synthetic lethal interaction when the presence of alteration of the homologous repair pathway was observed. PARP is involved in multiple aspects of DNA repair, and the PARP inhibitor Olaparib has recently been approved for treating ovarian cancers with BRCA1/2 mutations. In addition, it showed that using a high-throughput, next-generation sequencing assay in prostate cancer, detection of genomic alteration in genes involved in homologous repair pathway BRCA2, ATM, BRCA1, PALB2, CHEK2, FANCA, and HDAC2, is associated with response to olaparib. Thus demonstrating the clinical validation of the usage of precision medicine to position PARP inhibitor like olaparib in different cancer types based on molecular analysis.
Preclinical studies showed DNA damage promotes neoantigen expression. It is possible that increased DNA damage by PARPi would yield greater mutational burden and expand neoantigen expression, leading to greater immune recognition of the tumor. PARPi is also associated with immunomodulation. The PARPi talazoparib increases the number of peritoneal CD8+ T cells and natural killer cells and increases production of interferon (IFN)-γ and tumor necrosis factor-α in a BRCA1-mutated ovarian cancer xenograft model. Hence, addition of PARPi to immune checkpoint blockade could complement the clinical benefit of immune checkpoint inhibition.
Such high level of mutation results in high number of neoantigen and antitumor immune response thus given the rational to use immunotherapy to target such type. A recent paper validate this strategy using the anti PD-1 pembrolizumab Some case reports suggest also that other mutations that induce hypermutated tumor (POLD, POLE, or MYH) could gain benefit from anti PD-1 therapy. Additional DNA repair machinery dysfunction may lead to accumulation of mutations. And such level of mutations could induce better response to immunotherapy. In the lung non-small cell setting high mutation rate were associated with better efficacy of both nivolumab and pembrolizumab.
- Conditions
- Immunotherapy
- Being tested
- olaparib, durvalumab, tremelimumab
- Keywords
- immunotherapy, olaparib, durvalumab, tremelimumab, genes mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olaparib, durvalumab, tremelimumabDrug
STEP 1:
Olaparib 300 mg BID during 8 weeks. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib tablets can be taken with or without food
STEP 2:
Olaparib 300 mg during 4 months as per same requirement as below. Durvalumab 1500 mg plus tremelimumab 75 mg via IV infusion Q4W, starting on Week 0, for up to a maximum of 4 doses followed by durvalumab monotherapy 1500 mg via IV infusion Q4W, starting 4 weeks after the last infusion of the combination and in response or stable after prior molecular target therapy by olaparib based on molecular sequencing.
| Study group | Role | What they receive |
|---|---|---|
| GUIDE2REPAIR patients | Experimental | olaparib + immunotherapy (durvalumab + tremelimumab) during 4 months followed by durvalumab alone as maintenance in patients with solid cancer and in response or stable after prior molecular target therapy by olaparib based on molecular sequencing. Receives: Drug: olaparib, durvalumab, tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessments: progression free survival
progression free survival
Measured: 6 months after the initiation of immunotherapy for all cohorts excepted for ovarian cohort where PFS will be evaluated at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start10 Feb 2020
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
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 ImmunotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- François GHIRINGHELLI, Principal investigator, Centre Georges Francois Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169841
- Sponsor's protocol ID
- GUIDE2REPAIR
- Acronym
- GUIDE2REPAIR
- Status last verified
- Feb 2024
- First submitted
- 18 Nov 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fumet JD, Limagne E, Thibaudin M, Truntzer C, Bertaut A, Rederstorff E, Ghiringhelli F. Precision medicine phase II study evaluating the efficacy of a double immunotherapy by durvalumab and tremelimumab combined with olaparib in patients with solid cancers and carriers of homologous recombination repair genes mutation in response or stable after olaparib treatment. BMC Cancer. 2020 Aug 10;20(1):748. doi: 10.1186/s12885-020-07253-x.
PubMed 32778095
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine Phase II Study Evaluating the Efficacy of a Double Immunotherapy by Durvalumab and Tremelimumab Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes Mutation in Response or Stable After Olaparib Treatment
- ClinicalTrials.gov ID
- NCT04169841
- Acronym / sponsor ID
- GUIDE2REPAIR / GUIDE2REPAIR
- Conditions
- Immunotherapy
- Keywords
- immunotherapy, olaparib, durvalumab, tremelimumab, genes mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 20 Nov 2019 (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.
The study propose to generate a clinical trial based on precision medicine to evaluate the use of immunotherapy in patients with altered homologous recombination repair genes and without progression after prior targeted therapy.
Detailed description
With the development of cost effective and rapid technology of genome sequencing, precision medicine becomes a new way to think oncology. Current targets involve mainly tyrosine kinase, but DNA repair machinery could also be targetable. Some of DNA repair aberrations have been associated with sensitivity to platinum and poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors like Olaparib, suggesting that treatment with a PARP inhibitor may exploit a synthetic lethal interaction when the presence of alteration of the homologous repair pathway was observed. PARP is involved in multiple aspects of DNA repair, and the PARP inhibitor Olaparib has recently been approved for treating ovarian cancers with BRCA1/2 mutations. In addition, it showed that using a high-throughput, next-generation sequencing assay in prostate cancer, detection of genomic alteration in genes involved in homologous repair pathway BRCA2, ATM, BRCA1, PALB2, CHEK2, FANCA, and HDAC2, is associated with response to olaparib. Thus demonstrating the clinical validation of the usage of precision medicine to position PARP inhibitor like olaparib in different cancer types based on molecular analysis.
Preclinical studies showed DNA damage promotes neoantigen expression. It is possible that increased DNA damage by PARPi would yield greater mutational burden and expand neoantigen expression, leading to greater immune recognition of the tumor. PARPi is also associated with immunomodulation. The PARPi talazoparib increases the number of peritoneal CD8+ T cells and natural killer cells and increases production of interferon (IFN)-γ and tumor necrosis factor-α in a BRCA1-mutated ovarian cancer xenograft model. Hence, addition of PARPi to immune checkpoint blockade could complement the clinical benefit of immune checkpoint inhibition.
Such high level of mutation results in high number of neoantigen and antitumor immune response thus given the rational to use immunotherapy to target such type. A recent paper validate this strategy using the anti PD-1 pembrolizumab Some case reports suggest also that other mutations that induce hypermutated tumor (POLD, POLE, or MYH) could gain benefit from anti PD-1 therapy. Additional DNA repair machinery dysfunction may lead to accumulation of mutations. And such level of mutations could induce better response to immunotherapy. In the lung non-small cell setting high mutation rate were associated with better efficacy of both nivolumab and pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GUIDE2REPAIR patients | Experimental | Drug: olaparib, durvalumab, tremelimumabolaparib + immunotherapy (durvalumab + tremelimumab) during 4 months followed by durvalumab alone as maintenance in patients with solid cancer and in response or stable after prior molecular target therapy by olaparib based on molecular sequencing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Capable of giving signed informed consent
- Exome sequencing of tumor and constitutive DNA should have been already performed
- Patients must be diagnosed with a solid malignancy with the following cancer histologically confirmed with specified inclusion for each cohort:
- Metastatic head and Neck cancer
- Metastatic endometrial cancer • Progression after 1 prior systemic, platinum-based chemotherapy regimen for EC. Participants may have received up to 1 additional line of platinum-based chemotherapy if given in the neoadjuvant or adjuvant treatment setting. There is no restriction regarding prior hormonal therapy
Key exclusion criteria (41 listed)
- Involvement in the planning and/or conduct of the study
- Patient with mBRCA1 / 2 that are eligible for current marketing authorization for olaparib (ovarian cancer),and patient eligible for AstraZeneca registration clinical trials, particularly for the prostate cohort
- Specific exclusion criteria each cohort:
- Metastatic lung cancer
- Metastatic prostate cancer
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 |
|---|---|---|
| olaparib, durvalumab, tremelimumabSTEP 1: Olaparib 300 mg BID during 8 weeks. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib tablets can be taken with or without food STEP 2: Olaparib 300 mg during 4 months as per same requirement as below. Durvalumab 1500 mg plus tremelimumab 75 mg via IV infusion Q4W, starting on Week 0, for up to a maximum of 4 doses followed by durvalumab monotherapy 1500 mg via IV infusion Q4W, starting 4 weeks after the last infusion of the combination and in response or stable after prior molecular target therapy by olaparib based on molecular sequencing. | Drug | GUIDE2REPAIR patients |
Primary outcome
Safety Assessments: progression free survival
Time frame: 6 months after the initiation of immunotherapy for all cohorts excepted for ovarian cohort where PFS will be evaluated at 12 months.
progression free survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 32778095Fumet JD, Limagne E, Thibaudin M, Truntzer C, Bertaut A, Rederstorff E, Ghiringhelli F. Precision medicine phase II study evaluating the efficacy of a double immunotherapy by durvalumab and tremelimumab combined with olaparib in patients with solid cancers and carriers of homologous recombination repair genes mutation in response or stable after olaparib treatment. BMC Cancer. 2020 Aug 10;20(1):748. doi: 10.1186/s12885-020-07253-x.
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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.
François GHIRINGHELLI principal investigator
Centre Georges Francois Leclerc
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing olaparib, durvalumab, tremelimumab in people with Immunotherapy, run by Centre Georges Francois Leclerc at 8 sites in France.
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 34 inclusion and 41 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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
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 Assessments: progression free survival (time frame: 6 months after the initiation of immunotherapy for all cohorts excepted for ovarian cohort where PFS will be evaluated at 12 months.). 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 NCT04169841, 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 13 Feb 2024.